Southern Diet Called Single Biggest Factor in Hypertension Racial Disparities

Several clinical and social factors have contributed to the higher rates of hypertension among black American adults, but key among them is the “Southern diet,” a prospective cohort study found.

Such a diet — calorie-dense with relatively little fresh fruit and vegetables or whole grains — was the largest statistical mediator of difference in hypertension prevalence between black and whites, accounting for 29.2% of the excess risk among black women and 51.6% of the excess risk among black men, reported George Howard, DrPH, of the University of Alabama at Birmingham, and colleagues in JAMA.

The researchers found a greater number of significant mediating factors among women than men for the racial disparity in hypertension incidence, which “may be partially attributable to an observed stronger association of race with incident hypertension among women than men that would provide greater statistical power to detect mediating factors,” they wrote.

This study provided a look into “some of the unique lifestyle choices that individuals make in terms of diet and exercise and other factors that may be contributing to a more likely development of hypertension and as such it is a non-biased assessment of diet and exercise and alcohol and smoking and all the other factors that we presume contribute to hypertension,” commented Donald Molony, MD, of University of Texas Health Science Center in Houston, in an interview with MedPage Today.

The researchers evaluated 6,897 participants (mean age 62), among whom 26% were black and 55% were women. Over the course of the study, 46% of black participants and 33% of white participants developed hypertension in a follow-up visit 9.4 years later.

Black participants scored higher on the adjusted mean Southern diet scale, which ranges from -4.5 to 8.2 and where higher values are associated with higher intake of fried foods, organ meats, processed meats, eggs, added fats, high-fat dairy, sugar-sweetened beverages, and bread. The researchers found the following average scores:

• Black men: 0.81 (95% CI, 0.72 to 0.90)
• White men: -0.26 (95% CI, -0.31 to -0.21)
• Black women: 0.27 (95% CI, 0.20 to 0.33)
• White women: -0.57 (95% CI, -0.61 to -0.54)

Higher Southern diet scores were significantly linked with incident hypertension for women (OR 1.17 per 1 SD; 95% CI, 1.08-1.28) and for men (1.16 per 1 SD; 95% CI, 1.06 to 1.27).

Among black men, two other factors were significant — a higher dietary ratio of sodium to potassium and an educational level of graduating high school or even less each accounted for 12.3% of the excess hypertension risk compared with white men.

Among black women, the proportion of excess risk mediated by the various risk factors was:

• 18.3% for higher body mass index
• 15.2% for a larger waist
• 11.2% for lower adherence to the Dietary Approaches to Stop Hypertension (DASH) diet
• 9.3% for income level of $35,000 or less
• 6.8% for higher dietary ratio of sodium to potassium
• 4.1% for education level of high school graduate or less

Comment on the study’s findings, Molony noted that there was “little evidence from this cohort that alcohol consumption and lifestyle stresses are contributing significantly to hypertension.”

Perceived stress levels reported by the participants were similar between black and white groups by gender.

However, Molony questioned that finding. “I’m concerned about the stress issue, because I don’t think that the measurements that they used are sensitive enough to look at daily stresses on the development of hypertension. More importantly, if stress is a factor in the development of hypertension in the African American population, then it might be more important in the younger age groups that are excluded from the study,” Molony continued.

The researchers acknowledged the limitations of their work: over half of the cohort did not have a follow-up visit, 16% passed away, and 24% did not complete the study because they withdrew or declined follow-up.

The investigators also noted the potential for measurement error and misclassification of mediating factors. “Such misclassification would generally lead to underestimation of the effects of potential mediating factors, so the reported estimates of the mediating effects could be underestimates,” the investigators wrote.

The study was funded by the National Institute of Neurological Disorders and Stroke.

Howard and Molony did not disclose any relevant financial relationships with industry.

• Primary Source

  JAMA

  Source Reference: Howard G, et al “Association of clinical and social factors with excess hypertension risk in black compared with white US adults” JAMA 2018; DOI: 10.1001/jama.2018.13467.

https://www.medpagetoday.com/cardiology/hypertension/75456

FDA Conducts Surprise Inspection of E-Cig Maker

FDA investigators seized more than a thousand pages of documents from the San Francisco corporate headquarters of electronic cigarette maker JUUL Labs, agency officials confirmed Tuesday.

The surprise on-site inspection, and seizure of sales and marketing documents, late last week followed FDA Commissioner Scott Gottlieb’s written request to JUUL Labs asking for documents to help agency officials understand and address the reasons for the reported skyrocketing increase in sales of the e-cigarette brand to teens.

The CDC reported Tuesday that sales of JUULs, which are shaped like USB flash drives, grew more than seven-fold from 2016 to 2017, and that the brand was the top selling e-cigarette in the U.S. starting in December 2017.

Prior to late 2017, British American Tobacco had the largest share of the e-cigarette market in the U.S., wrote Brian A. King, PhD, MPH, of the CDC in Atlanta, and colleagues in a research letter in JAMA.

Sales of JUUL e-cigarettes increased 641% from 2016 to 2017 and by December 2017, JUUL Labs’ monthly e-cigarette sales surpassed those of British American Tobacco, the investigators wrote.

The CDC study did not address the reasons for the rapid growth in JUUL sales, but anecdotal reports suggest that the brand is wildly popular among teens, who are attracted to the unique shape and appealing flavors like creme brulee, mango, and cool cucumber.

In September, Gottlieb declared teen use of electronic cigarettes an “epidemic,” as he announced what he termed “the largest coordinated tobacco compliance effort in FDA’s history” to address the issue.

The FDA commissioner acknowledged that federal health officials were slow to recognize the growing popularity of JUUL and other e-cigarettes among teens. To address adolescent use, the FDA may shorten the time that most e-cigarettes now being sold can stay on the market without review. A previously announced FDA extension of the review deadline was widely criticized by anti-smoking groups. FDA is also considering banning some or all e-cigarette flavorings.

In his earlier remarks, Gottlieb criticized e-cigarette manufacturers for failing to address teen use of their products.

“I’ve been warning the e-cigarette industry for more than a year that they needed to do much more to stem the youth trends,” he said at the time. “In my view, they treated these issues like a public relations challenge rather than seriously considering their legal obligations, the public health mandate, and the existential threat to these products. And the risks mounted.”

In a statement addressing last week’s on-site inspection of JUUL Labs corporate headquarters, FDA officials revealed that several contract manufacturer facilities had also been visited, with the goal of assessing compliance with all applicable FDA laws and regulatory requirements.

“The new and highly disturbing data we have on youth use demonstrates plainly that e-cigarettes are creating an epidemic of access to these products among kids,” the statement read.

The study by King’s group was funded by the CDC. King and co-authors disclosed no relevant relationships with industry.

LAST UPDATED 10.02.2018

• Primary Source

  JAMA

  Source Reference: King BA, et al “Electronic cigarette sales in the United States, 2013-2017” JAMA 2018;320:1379-1380.

https://www.medpagetoday.com/primarycare/smoking/75455

Momenta calls time on biosimilar R&D, cuts half its staff

Momenta’s foray into the biosimilars business has come to a sad end, with the company slashing staff and programs as it refocuses on its novel drug pipeline targeted at immune disorders.

Cambridge, Massachusetts-based Momenta is shedding 110 staff—around 50% of its workforce—and most of those will be gone within the next few days as it tries to slash $250 million off its costs in the next five years. The cull includes five of the company’s senior executives including Chief Operating Officer Ganesh Kaundinya, who also serves as Momenta’s chief scientific officer, and cuts the company’s executive team in half.

The decision says a lot about the state of the U.S. biosimilars market, which hasn’t yet taken off in the way it has in Europe where more than 40 biosimilar products have been approved and—in some cases—dominate national markets. To date, about a dozen biosimilars have been approved by the FDA, and only a handful have been launched.

That slow growth has been put down to a sluggish regulatory process, access-delaying patent litigation and the fact that the agency hasn’t yet agreed that any biosimilar meets its criteria for being therapeutically interchangeable with the reference drug, which has hampered uptake by prescribers.

Momenta currently has seven biosimilars in its pipeline and is hoping to transfer the rights to five of them to development partner Mylan, with negotiations are ongoing right now, including a late-stage version of Bristol-Myers Squibb’s arthritis drug Orencia. It will, however, retain rights to a version of eye disease drug Eylea developed under the partnership, as well as an in-house biosimilar of AbbVie’s immunology drug Humira, which have advanced to late-stage development.

The company had hoped to transfer the rights to the whole portfolio, according to President and CEO Craig Wheeler, who said on a conference call that the initial aim was to cut its spending on biosimilars entirely and bring in new funding for the novel pipeline, headed by anti-FcRn antibody M281 for immunoglobulin G mediated diseases which has cleared a phase 1 trial.

The intention was to sell the division outright or find some other way to hive it off, but that plan was scuttled by problems including “overlapping” portfolios as well as an “increasingly challenging political climate associated with international investment in U.S. business.”

“As a result, we have made the decision to restructure the company on our own,” said Wheeler. He acknowledged that retaining two late-stage biosimilar programs will keep short-term spending higher, but with the potential payoff of revenue streams that can support the novel pipeline.

The wholly owned Humira biosimilar is scheduled for filing in the U.S. before the end of the year and in Europe in early 2019, but Momenta is hoping for revenues from Europe first—possibly in 2020—and is looking for a commercial partner for the program.

Wheeler says the Mylan-partnered Eylea drug, in phase 3, is in the lead versus other biosimilars and could launch in 2023, with “high potential” commercially.

Most of the staff losses will be in the biosimilars team, but Momenta is also cutting its research staff that work outside the scope of its main pipeline programs. Along with M281, that includes recombinant Fc multimer M230 and intravenous immunoglobulin M254—all three of which will start proof-of-concept trials in the next four months.

The company ended the second quarter with $321 million in cash and estimates the restructuring will cost $17 million to $20 million through 2018. Wheeler said additional fundraising will probably be needed in 2020 as the pipeline develops.

https://www.fiercebiotech.com/biotech/momenta-calls-time-biosimilar-r-d-cutting-half-its-staff

Abbott next-gen FreeStyle Libre Continuous Glucose Monitor CE Mark’d

Abbott (ABT +0.8%) announces that its next-generation FreeStyle Libre 2 continuous glucose monitoring (CGM) system is now CE Mark certified. The device includes alarms to alert the user when blood sugar levels are out of range and an alarm if the sensor loses communication with the reader.

Market rollout will commence in the coming weeks.

Competitors DexCom (DXCM -5.1%) and Tandem Diabetes Care (TNDM-5.5%) were down on the news.

https://seekingalpha.com/news/3394129-abbotts-next-gen-freestyle-libre-cgm-ce-markd

William Blair says market ‘significantly’ undervaluing Portola’s Andexxa

William Blair analyst Matt Phipps says a call he hosted yesterday with Jean Marie Connors, M.D., associate professor of medicine and medical director of the hemostatic and antithrombotic stewardship program and anticoagulation management service at Brigham and Women’s Hospital, to discuss the use of reversal agents in patients who experience major bleeding events on anticoagulants such as factor Xa inhibitors, highlighted the “significant opportunity” for Portola Pharmaceuticals’ Andexxa. The call put a spotlight on the “sizable market opportunity” for Andexxa once the commercial supply amendment is approved, Phipps tells investors in a research note. The analyst continues to believe Andexxa has blockbuster potential based on the “significant and growing market opportunity” for the reversal of factor Xa inhibitors. Further, he sees an opportunity for increased utilization following approval in patients requiring emergency surgery, potentially increasing the average patients per month treated with Andexxa. The analyst believes the market continues to “significantly undervalue” the potential of Andexxa, as well as near-term catalysts for Portola, including expanding commercialization across the United States and regulatory approval in Europe. He keeps an Outperform rating on the shares.
https://thefly.com/landingPageNews.php?id=2798659

Inovio gains after positive data published

Shares of Inovio (INO) are spiking higher after the company announced the publication of results in a major cancer journal, from a study of MEDI0457. TREATED WITH MEDI0457: According to an earlier statement from Inovio, a paper published in a major cancer journal detailed results of a patient with head and neck cancer treated with MEDI0457 achieved a sustained complete response on treatment with a subsequent PD-1 checkpoint inhibitor. In the Inovio-sponsored study of 22 patients with head and neck squamous cell carcinoma, the company reported 91% showed T cell activity in the blood or tissue. MEDI0457 — formerly called INO-3112 — was in 2015 licensed to MedImmune, the global biologics research and development arm of AstraZeneca (AZN). These immune data, as well as the financial terms of the license agreement, have been previously reported by Inovio. STUDY SUPPORTS HPV AND ONCOLOGY PROGRAMS: Inovio CEO Dr. J. Joseph Kim said, “We are buoyed by the study as it lends support to all of our HPV and oncology programs. These data demonstrated that Inovio’s technology based in MEDI0457 can generate durable HPV16/18 antigen-specific peripheral and tumor immune responses. The study supports our belief that this approach may be used as a complementary strategy to PD-1/PD-L1 inhibition in HPV-associated head and neck and other types of cancer to improve therapeutic outcomes. Inovio is collaborating with MedImmune as well as Genentech (RHHBY) and Regeneron (REGN) in efficacy trials coupling Inovio’s DNA-based cancer immunotherapies with checkpoint inhibitors designed to increase response rates with data expected in 2019.” ANALYST RAISES PRICE TARGET: Stifel analyst Stephen Willey resumed coverage of Inovio with a Buy rating and $8 price target, citing his favorable view of the clinical risk underlying the ongoing Phase 3 VGX-3100 development program in patients with HPV+ cervical HSIL. He sees the company’s earlier-stage immuno-oncology development efforts and externally-funded infectious diseases programs as additional sources of longer-term upside. PRICE ACTION: Shares of Inovio Pharmaceuticals are up over 16% to $6.22 per share in afternoon trading.

https://thefly.com/landingPageNews.php?id=2798674

Rexahn presents prelim Phase 2a data on pancreatic cancer med

Rexahn Pharmaceuticals announced earlier that preliminary safety and efficacy data from the ongoing Phase 2a clinical trial of RX-3117 in combination with Abraxane in patients newly diagnosed with metastatic pancreatic cancer were being presented in a poster presentation at the fifth NCI Pancreatic Cancer Symposium held October 2-3, 2018 at the National Institutes of Health. “These preliminary data are encouraging, showing that the combined administration of RX-3117 and Abraxane in newly diagnosed metastatic pancreatic cancer patients appears to be safe and well tolerated and showing evidence of clinical activity. As of September 19, 2018, there was one complete response and three partial responses from the first 14 evaluable patients. In addition, there were eight patients with stable disease who had tumor reductions of up to 16% and who are still being actively dosed. We are encouraged by this preliminary data reflecting a disease control rate of 86% and an overall response rate of 29%. We look forward to completing the study enrollment and plan to report the final data in 2019,” said Dr. Ely Benaim, M.D., chief medical officer of Rexahn. “The safety profile of RX-3117 continues to be encouraging as it can be administered at its recommended Phase 2 dose together with the maximal labeled dose of Abraxane without producing an increase in severe adverse events. This differs from current standard of care where the doses of both gemcitabine and Abraxane, when given in combination, may have to be reduced to avoid grade 3 and 4 dose limiting toxicities,” added CEO Peter Suzdak.
https://thefly.com/landingPageNews.php?id=2798615