Hello. I’m Dr Arefa Cassoobhoy, a practicing internist, Medscape advisor, and senior medical director for WebMD. Welcome to Medscape Morning Report, our 1-minute news story for primary care.
There may be some good news for people who suffer from migraine headaches. Another device is now FDA-approved for prevention, and it’s already used for treating acute pain from migraines. The Spring TMS device delivers single-pulse transcranial magnetic stimulation to the brains of chronic migraine sufferers.
According to a new study, daily prophylactic treatment for 3 months, which consists of four pulses twice a day, can reduce the number of headache days by almost one third.
The study included over 130 patients who experienced migraines on at least 4 days per month which lasted for 4 hours or more. The participants completed a 28-day headache diary before starting the 3-month protocol and reported a mean of about 9 headache days per month at baseline. After treatment, this dropped by 2.75 days.
What’s even more encouraging is that the technology has been used for years and has a good safety profile. Be on the lookout for this new option.
Using RNA interference to inhibit proprotein convertase subtilisin kexin type 9 (PCSK9) synthesis lowers levels of atherogenic lipoproteins across the board, new results suggest.
The findings come from secondary analysis of data from the ORION 1 trial, published in 2017 in the New England Journal of Medicine. The trial showed that long-acting RNA interference within hepatocytes by inclisiran (ALN-PCSsc, Alnylam Pharmaceuticals/The Medicines Company) offers long-lasting reductions in low-density lipoprotein (LDL) cholesterol levels.
As reported by theheart.org | Medscape Cardiology at that time,the phase 2 trial showed that inclisiran injection, tested at various doses, led to a mean reduction in LDL cholesterol from baseline to day 180 of 27.9% to 41.9% vs a 2.1% increase with placebo (P < .001).
The findings suggested that inclisiran could be given as little as once every 6 months, as opposed to an injection every few weeks with the antibody-based PCSK9 inhibitors alirocumab (Praluent, Sanofi/Regeneron) and evolocumab (Repatha, Amgen).
The current analysis, presented at the European Atherosclerosis Society (EAS) 2018 meeting and published online May 7 in Circulation, are derived from a prespecified secondary analysis looking at the impact of the drug on atherogenic lipoproteins.
At 180 days, inclisiran substantially reduced levels of non–high-density (HDL) cholesterol, apolipoprotein B, and lipoprotein(a) [Lp(a)], among other lipoproteins, and most patients met guideline-recommended targets for non-HDL cholesterol and apolipoprotein B, the researchers report.
Kausik Ray, MD, PhD, the Imperial Centre for Cardiovascular Disease Prevention, Imperial College London, United Kingdom, who presented the results and is also principal investigator, said that the findings in the current analysis “are consistent with what we’ve seen” in the main study.
He told theheart.org | Medscape Cardiology that “the next step is to show safety, and that’s why we’ve recruited 3660 patients across three large international studies, which will report phase 3 safety data and long-term efficacy data.”
They anticipate results of those studies should be available in the second half of 2019, he said, and would form the basis for approval applications to the European Medicines Agency and the US Food and Drug Administration.
Ray is also taking part in ORION IV, a cardiovascular outcomes study starting in 2018 that will involve around 15,000 patients from the United States and United Kingdom who are at high cardiovascular risk and have high HDL cholesterol.
“One of the reasons that I think we’re in a really good position with that is that one of the long-term challenges with all these therapies is keeping people on the study drug,” he said.
Consumer & Medical Devices Business Review will be held in New Brunswick, NJ on May 16 at 8:30 am. Webcast Link: https://edge.media-server.com/m6/p/trmhmyqo
First lady Melania Trump underwent an “embolization procedure” to treat a benign kidney condition, the White House said Monday.
The first lady’s office said in a statement that the procedure was “successful and there were no complications.”
“Mrs. Trump is at Walter Reed National Military Medical Center and will likely remain there for the duration of the week. The First Lady looks forward to a full recovery so she can continue her work on behalf of children everywhere,” the statement added.
Spokeswoman Stephanie Grisham confirmed to CBS News that the president will visit Walter Reed later today. Grisham, who has visited the first lady, later told CBS News that the first lady is “doing very well” and is in “good spirits.”
The president spoke with the first lady before the procedure, and he also spoke to the doctor after the procedure had been finished, a White House official said. The president visited the first lady late Monday afternoon and tweeted that he was going to see her, adding, “Successful procedure, she is in good spirits. Thank you to all of the well-wishers!”
Donald J. Trump
@realDonaldTrump
Heading over to Walter Reed Medical Center to see our great First Lady, Melania. Successful procedure, she is in good spirits. Thank you to all of the well-wishers!
The first lady most recently appeared at the White House to unveil her “Be Best” campaign in a Rose Garden ceremony on Monday last week.
What is a kidney embolization procedure?
While many details of the first lady’s condition are not publicly known, CBS News chief medical correspondent Dr. Jon LaPook explained the procedure in general terms.
“It involves cutting off the arterial blood supply to something… [Doctors] put some substance into an artery that’s feeding whatever this benign condition is that they’re treating and then that cuts off the blood supply, cuts off the oxygen and whatever they’re treating would presumably shrink and start to be less important than it was before.”
One example of a benign growth on the kidneys that may be treated with an embolization procedure is an angiomyolipoma, or a benign collection of fat and muscle.
“It does tend to happen more in women than in men and it tends to be in middle age,” LaPook said.
There are a number of ways angiomyolipoma can be discovered, he explained. It can lead to pain and blood in urine as it grows or it could cause no symptoms and be found during routine imaging tests.
Other conditions an embolization procedure could be used to treat include aneurysms, or a bulge of an artery, and arteriovenous malformation, or abnormal connection between an artery and vein.
While there’s no indication whether Mrs. Trump’s procedure was an emergency or planned, LaPook said after this kind of procedure, it would not be at all unusual to keep her in the hospital for observation for a number of days.
“You can get pretty sick after an embolization because there’s a lot of inflammation that can go on you can get a fever and you want to make sure there are no complications like abnormal bleeding or infection,” he said, though he emphasized that it is normally a very safe procedure.
Gilead Sciences Inc. ( GILD ) announced that the U.S. Food and Drug Administration has approved once-daily oral Truvada (emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg)—in combination with safer sex practices—to reduce the risk of sexually acquired HIV-1 in at-risk adolescents.
The safety and efficacy profile of Truvada for HIV prevention in uninfected adults, a strategy called pre-exposure prophylaxis (PrEP), is well established, and Truvada for PrEP was first approved for use in adults in 2012.
The addition of the adolescent indication is based on a study in HIV-negative individuals 15 to 17 years of age. In the United States, adolescents and young adults 13 to 24 years of age comprised 21 percent of all new infections in 2016, according to the U.S. Centers for Disease Control and Prevention, and 81 percent of those infections were among young men who have sex with men or YMSM.
Truvada for PrEP is now indicated in combination with safer sex practices to reduce the risk of sexually acquired HIV-1 in at-risk adults and adolescents weighing at least 35 kg. Individuals must have a negative HIV test immediately prior to initiating Truvada for PrEP.
Truvada has a boxed warning in its product label regarding the risks of post treatment acute exacerbation of hepatitis B and the risk of drug resistance with the use of Truvada for PrEP in undiagnosed early HIV infection. Further important safety information, adverse drug reactions and prescribing considerations are included below.
The company noted that Truvada does not prevent other sexually transmitted infections or cure HIV infection or AIDS.
Merck said Tuesday that despite attaining organic growth its first-quarter sales declined, dragged down by currency headwinds.
The company reported a 4.4% sales decline to 3.69 billion euros ($4.41 billion), affected by negative exchange rates. Its net income decreased to EUR341 million, dropping 35% from EUR523 million in the same period a year earlier.
Earnings before interest, taxes, depreciation and amortization before one-time items, or Ebitda–an important figure for the company–were EUR1.01 billion, down from EUR1.24 billion. The company said favorable one-time effects in its healthcare sector buoyed numbers from the year before.
According to consensus estimates compiled by FactSet, the company was expected to post sales of EUR3.70 billion, Ebitda of EUR998 million and net income of EUR596 million.
Merck said it continues to expect a moderate organic net sales increase of between 3% and 5% in 2018, with sales in the region of EUR15 billion to EUR15.5 billion. The planned sale of its consumer-health business to Procter & Gamble Co. (PG) is likely to reduce group sales by between EUR900 million-EUR1 billion, lowering sales estimates to between EUR14 billion and EUR14.5 billion. Ebitda before exceptional items are expected to be between EUR3.95 billion and EUR4.15 billion.
The Darmstadt, Germany-based multinational’s drug pipeline suffered a series of setbacks. Drug Avelumab, co-developed with Pfizer, didn’t deliver in a lung-cancer study, whereas relapsing multiple sclerosis drug Evobrutinib met a Phase 2 trial endpoint.
Tepotinib, a cancer drug, received its first regulatory designation in Japan, with analysts closely watching its potential to treat a specific sub-population–at least 13,000 individuals in the U.S.–of lung cancer patients affected by mutation METex14. Wimal Kapadia, an analyst at Bernstein, sees Novartis Capmatinib and Pfizer’s Xalkori as likely competitors to the drug.
Just a few weeks out from ASCO, and with more than a touch of inevitability, Swiss major Roche is axing its IDO/TDO inhibitor work “in its entirety” with partner NewLink Genetics as the fallout from a string of weak IDO trials across biopharma continues.
The pair originally signed up to the pact back in October 2014, worth potentially around $1 billion (with $150 million upfront), but last summer this started to break up when Roche stopped work on an experimental IDO drug, handing back the rights to its partner.
This came after a series of trial hits for the biotech, with NewLink suffering a setback that same week after its IDO inhibitor indoximod, touted as one of the next big things in cancer research, failed to show any benefit in a metastatic breast cancer trial.
The result was yet another blow for NewLink, which has been in the doldrums since it revealed a pancreatic cancer vaccine failed a phase 3 trial in 2016, with patients receiving placebo actually living longer than those on its algenpantucel-L candidate. The finding cast serious doubts on the future of the company's HyperAcute platform cancer vaccine platform, which was subsequently parked by the company as it focused on its IDO inhibitor candidates.
Though backing out of work on that drug, Roche didn’t sever all ties, saying last June that the research collaboration with its biologics arm Genentech for work on the next-gen IDO/TDO (tryptophan 2,3-dioxygenase) inhibitors “continues”.
No longer, however. As per today's SEC filing: “On May 10, 2018, the company [NewLink] received notice from Genentech, a member of the Roche Group, that it is terminating the License and Collaboration Agreement between the parties dated October 14, 2014, or the Genentech Agreement, in its entirety. Such termination will become effective 180 days after our receipt of this notice from Genentech.
“Genentech had previously terminated the Genentech Agreement in part with respect to NLG919, but the agreement remained in force with respect to next generation IDO/TDO inhibitors identified through the research program conducted under the Genentech Agreement.
“Upon termination of the Genentech Agreement in its entirety, the Company’s rights in such next generation compounds will revert to the Company, and Genentech will grant to the Company an exclusive, worldwide, royalty-bearing, sublicensable license, under certain Genentech intellectual property, to research, develop, manufacture and commercialize such next generation compounds, and the Company will be required to pay a low single-digit royalty to Genentech on any sales of next generation compounds, should the Company proceed to develop and commercialize them.”
This comes after a torrid few months for IDO research: Just over a month ago, the combination of Incyte’s IDO1 inhibitor epacadostat and Merck & Co.’s blockbuster PD-1 star Keytruda was supposed to pose a major threat to rival Bristol-Myers Squibb’s melanoma franchise—but the data didn’t come through.
That phase 3 data found no benefit on progression-free survival for the duo compared to Keytruda alone—and little chance that the overall survival figures would rescue the study—and Incyte said the trial has been abandoned.
Then, a month later on May 1, Bristol-Myers Squibb pulled two phase 3 clinical trials of the IDO1 inhibitor it acquired through an $800 million takeover of Flexus, coming off the back of that Incyte trial.
On the same day, Incyte also took the ax to its suite of late-phase epacadostat trials after digesting the implications of that pivotal study blowup. The cull saw Incyte downgrade two pivotal epacadostat-Keytruda trials to phase 2 studies and back away from six other late-stage tests of its IDO inhibitor.
