UBS’s analyst Laura Sutcliffe upgrades rating from Neutral to Buy. Previously set at CHF 88, the target price has been raised to CHF 98.
Thursday, September 10, 2020
FDA OKs expanded use of Glaxo’s Trelegy Ellipta in asthma
The FDA has approved a new indication for GlaxoSmithKline (NYSE:GSK) and Innoviva’s (NASDAQ:INVA) Trelegy Ellipta (fluticasone furoate / umeclidinium / vilanterol ‘FF/UMEC/VI’) for the treatment of asthma in patients aged 18 years and older adding to its current license for use in patients with chronic obstructive pulmonary disease (COPD).
The FDA-approved strength for both COPD and asthma is FF/UMEC/VI 100/62.5/25mcg. There is an additional strength for asthma alone which is 200/62.5/25mcg.
The approval means Trelegy is the first single inhaler triple therapy for the maintenance treatment of both asthma and COPD in U.S.
FF/UMEC/VI is a combination of three molecules in a single inhaler that only needs to be taken in a single inhalation, once a day.
The company in-licensed the product from Innoviva (formerly Theravance).
https://seekingalpha.com/news/3612760-fda-oks-expanded-use-of-glaxos-trelegy-ellipta-in-asthma
Forte Bio up on positive FB-401 data in atopic dermatitis
Forte Biosciences (NASDAQ:FBRX) announces full results of Phase 1/2a trial of lead product candidate, FB-401 in atopic dermatitis (AD) patients in Science Translational Medicine.
In the pediatric cohort, 20 AD patients of age from 3 to 16 years of age, were treated topically with FB-401 for 16 weeks.
90% (18/20) of the pediatric patients reported at least a 50% improvement in the Eczema Activity and Severity Index (EASI-50) with 100% (9/9) of the moderate-to-severe patients achieving EASI-50.
The mean improvement in the EASI score was 77% with development observed on all actively treated body sites. Pruritus (itch) also improved by an average 58%.
The mechanism of action for FB-401 involves pathways that drive tissue repair and anti-inflammation.
Overall, FB-401 demonstrated excellent tolerability and significant improvement in disease activity in both adults and children.
Genentech Enspryng looks promising in neuromyelitis optica spectrum disorder
Roche (OTCQX:RHHBY) unit, Genentech will present new Enspryng (satralizumab) data on reducing relapse severity in the treatment of neuromyelitis optica spectrum disorder (NMOSD), a rare disease of the central nervous system. These data are being presented at MSVirtual2020.
In a post-hoc analysis of the Enspryng-treated group, the risk of severe relapse was reduced by 79% compared to placebo (5 of 27 [19%] vs. 12 of 34 [35%]), for patients across the double-blind periods of the SAkura studies.
Preventing relapses is the primary goal for NMOSD treatment management. The patients treated with Enspryng were also less likely to require rescue therapy for a relapse compared with placebo (OR 0.46; 95% CI, 0.25–0.86, p=0.015). A relapse was categorized as severe if it resulted in a change of ≥2 points on the Expanded Disability Status Scale.
In a separate pooled analysis, Enspryng reduced the risk of relapse in the combined double-blind period and open-label extension (OLE) by 51% (HR, 0.49; 95% CI, 0.31–0.79; p=0.002) compared to those originally in the placebo group. This effect was more pronounced in aquaporin-4 antibody (AQP4-IgG) seropositive patients, with 66% reduction in risk of relapse compared to the placebo group.
In the double-blind periods, infection rates were lower in the Enspryng-treated group compared to placebo in the SAkuraStar study (99.8 vs. 162.6 events/100 patient years [PY]), whereas infection rates did not differ between groups in the SAkuraSky study.
Satralizumab is an interleukin-6 (IL-6) receptor inhibitor. IL-6 is believed to pay a key role in NMOSD inflammation.
Previously: Roche’s satralizumab successful in second late-stage NMOSD study (Sept. 12, 2019)
AstraZeneca asthma drug succeeds late-stage OSTRO study; ADR listing to Nasdaq
AstraZeneca’s (NYSE:AZN) Fasrena evaluated in Phase III OSTRO trial in patients with chronic rhinosinusitis with nasal polyps (CRSwNP) met both co-primary endpoints.
Fasenra demonstrated a statistically significant improvement in the endoscopic total nasal polyp score (NPS) and the nasal blockage score (NBS) compared to placebo, in patients with nasal polyposis who were still symptomatic despite continued treatment with standard of care (SoC).
SoC consists of intranasal corticosteroids and prior surgery and/or use of systemic corticosteroids.
CRSwNP is an inflammatory disease associated with elevated levels of eosinophils in the upper respiratory tract and characterised by benign growths called nasal polyps.
Fasenra is currently approved as an add-on maintenance treatment for severe eosinophilic asthma.
Additionally, the Company will be transferring the listing of its American Depositary Receipts (ADRs) and its US-listed debt securities from NYSE to Nasdaq and Nasdaq Bond Exchange respectively, effective after market close on September 24.
ADRs and debt securities are expected to commence Nasdaq trading from September 25. The ADRs will continue to be listed as “AZN”.
“The change of stock exchange in the US will reduce overall listing cost for our equity and debt securities,” said Marc Dunoyer, Executive Director and CFO.
Wednesday, September 9, 2020
Clinical Outcomes in Young US Adults Hospitalized With COVID-19
Jonathan W. Cunningham, MD1; Muthiah Vaduganathan, MD, MPH1; Brian L. Claggett, PhD1; et al
doi:10.1001/jamainternmed.2020.5313
Coronavirus disease 2019 (COVID-19) is increasing rapidly among young adults in the US.1 Often described as a disease affecting older adults, to our knowledge, few studies have included younger patients to better understand their anticipated clinical trajectory. We investigated the clinical profile and outcomes of 3222 young adults (defined by the US Census as age 18-34 years) who required hospitalization for COVID-19 in the US. Methods
Young adults age 18 to 34 years with the International Statistical Classification of Diseases and Related Health Problems, Tenth Revision (ICD-10) code U07.1 (COVID-19, virus identified) discharged between April 1 and June 30, 2020, were identified in the Premier Healthcare Database, a hospital-based, all-payer database including 1030 US hospitals and health care systems and more than 8 million annual inpatient admissions.2,3 Pregnant young adults (n = 1644) were excluded because many were admitted for childbirth and not for COVID-19 infection. Only a patient’s first hospitalization for COVID-19 was considered.
Comorbidities and outcomes during COVID-19 hospitalization were defined using diagnosis, procedure, or billing ICD-10 codes. Intensive care utilization was defined by a billing code for intensive care unit room or daily ventilator management. Independent factors associated with the composite outcome of mechanical ventilation or death were identified by multivariable logistic regression. Race and ethnicity were reported by participating hospitals.
Data were collected and deidentified by Premier and transferred to and analyzed at Brigham and Women’s Hospital using Stata, version 14 (StataCorp). The Mass General Brigham institutional review board approved the study protocol; the requirement for informed consent was waived because of the deidentified nature of the data. A 2-sided P value of <.05 was considered significant. Results
Among 780 969 adults discharged between April 1, 2020, and June 30, 2020, 63 103 (8.1%) had the ICD-10 code for COVID-19, of whom 3222 (5%) were nonpregnant young adults (age 18-34 years) admitted to 419 US hospitals. The mean (SD) age of this population was 28.3 (4.4) years; 1849 (57.6%) were men and 1838 (57.0%) were Black or Hispanic. Overall, 1187 (36.8%) had obesity, 789 (24.5%) morbid obesity, 588 (18.2%) diabetes, and 519 (16.1%) hypertension (Table).
During hospitalization, 684 patients (21%) required intensive care, 331 (10%) required mechanical ventilation, and 88 (2.7%) died. Vasopressors or inotropes were used for 217 patients (7%), central venous catheters for 283 (9%), and arterial catheters for 192 (6%). The median length of stay was 4 days (interquartile range, 2-7 days). Among those who survived hospitalization, 99 (3%) were discharged to a postacute care facility.
Morbid obesity (adjusted odds ratio [OR], 2.30; 95% CI, 1.77-2.98; vs no obesity; P < .001) and hypertension (adjusted OR, 2.36; 95% CI, 1.79-3.12; P < .001) were common and in addition to male sex (adjusted OR, 1.53; 95% CI, 1.20-1.95; P = .001) were associated with greater risk of death or mechanical ventilation. Odds of death or mechanical ventilation did not vary significantly with race and ethnicity. Morbid obesity was present in 140 patients (41%) who died or required ventilation. Diabetes was associated with increased risk of this outcome in univariable analysis (OR, 1.82; 95% CI, 1.41-2.36; P < .001) but did not reach statistical significance after adjustment (adjusted OR, 1.31; 95% CI, 0.99-1.73; P = .06). Patients with multiple risk factors (morbid obesity, hypertension, and diabetes) faced risks similar to 8862 middle-aged (age 35-64 years) nonpregnant adults with COVID-19 infection without these conditions (Figure). Discussion
Young adults age 18 to 34 years hospitalized with COVID-19 experienced substantial rates of adverse outcomes: 21% required intensive care, 10% required mechanical ventilation, and 2.7% died. This in-hospital mortality rate is lower than that reported for older adults with COVID-19, but approximately double that of young adults with acute myocardial infarction.4 Morbid obesity, hypertension, and diabetes were common and associated with greater risks of adverse events. Young adults with more than 1 of these conditions faced risks comparable with those observed in middle-aged adults without them. More than half of these patients requiring hospitalization were Black or Hispanic, consistent with prior findings of disproportionate illness severity in these demographic groups.5,6
Limitations of this study included defining COVID-19 infection and comorbidities by ICD-10 codes, which may be subject to misclassification, and variable reporting of race and ethnicity across hospitals. The definition of COVID-19 infection did not require microbiological confirmation. Given the sharply rising rates of COVID-19 infection in young adults, these findings underscore the importance of infection prevention measures in this age group.
Can technology remove the COVID-19 risk from planes?
Across the world, the aviation industry is scrambling to find ways to keep the COVID-19 risk out of airplanes with high-tech filtration and advanced cleaning. American Airlines has partnered with medical advisers at Vanderbilt University and its competitors have made similar moves. Every airline is requiring masks. Southwest Airlines has adopted the “Southwest Promise,” which includes limiting capacity on flights to allow passengers to social distance.
As the COVID-19 pandemic continues to turn the airline industry upside down with no end in sight, suppliers are preparing for the inevitable future where cleanliness and germ-fighting is a high priority for customers.
North Texas manufacturer Aereos thinks antimicrobial plastics may be one solution to help cut the risk of spreading COVID-19 on commercial airline flights. And Dallas-based Allied BioScience has gotten government approval to spray a disinfectant coating in planes that’s billed as killing germs for up to a week.
With commercial air traffic still at historic lows and passengers continually wary of flying, Aereos says it has brought antimicrobial technology to high-touch surfaces inside commercial jetliners, such as tray tables, armrests, door handles and toilets.
The antimicrobial technology can cut down on the growth of germs and virus such as COVID-19, Aereos partner David Baker said.
“It’s just starting to catch a lot of interest,” said Baker, whose company recently released the line. “Especially considering that it’s a pandemic, it’s one way of making them feel comfortable. This provides them with a layer of protection.”
Fort Worth-based American Airlines and Allied BioScience received emergency approval last month from the Environmental Protection Agency for a spray-on coating product that is intended to protect against COVID-19 and other germs for at least a week.
The perception of heightened cleaning and hygiene on commercial aircraft is a “huge deal” to consumers during the COVID-19 pandemic, said Jamie Larounis, a travel consultant and writer for Upgradedpoints.com.
“This, in combination with social distancing efforts, is what is building consumer confidence that the airlines are doing their part to provide a safe experience,” Larounis said.
It’s unclear how much of the novel coronavirus is spread via surfaces, but airlines are still touting enhanced cleaning procedures along with state-of-the-art air filtering technologies, face masks and social distancing. Companies are experimenting with ultraviolet lighting to help kill COVID-19 and Southwest is testing thermal imaging cameras to detect fevers among passengers.
“The primary and most important mode of transmission for COVID-19 is through close contact from person-to-person,” according to the Centers for Disease Control and Prevention. “Based on data from lab studies on COVID-19 and what we know about similar respiratory diseases, it may be possible that a person can get COVID-19 by touching a surface or object that has the virus on it and then touching their own mouth, nose, or possibly their eyes, but this isn’t thought to be the main way the virus spreads.”
Aereos, based in Euless, makes replacement interior airplane parts and custom cabin items, such as tray tables, latches, toilet seats and window shades along with carts and other items used by flight attendants. Baker said the company started experimenting with antimicrobial additives on those parts in May and has them ready for sale to airlines looking to replace aircraft parts.
Aereos makes the parts at its North Texas manufacturing facility. The company also does work in the aerospace sector in maintenance, overhaul and defense, but the COVID-19 pandemic has created problems for nearly every corner of the airline industry, Baker said.
The antimicrobial technology has grown popular over the last decade in hospitals to cut down on infections and in some medical supplies and devices. The plastics don’t completely kill viruses such as COVID-19 on contact but instead work to inhibit the growth of viruses and germs, slowing down the life of contagions.
“Current evidence suggests that SARS-CoV-2 may remain viable for hours to days on surfaces made from a variety of materials,” according to the CDC’s website.
That leaves airlines, airports and even government agencies working to reduce touch points during the air travel experience at security screening points, at gates and on airplanes—evidence at least that there is concern that touching objects can spread viruses.
Baker said he doesn’t have any independent research on how effective the plastics are, but tests within the company have been promising.
“Very little had to be changed about what we do, and it essentially costs nothing extra,” Baker said. “We don’t expect airlines to go out and replace every single part, but you could start replacing parts as they break or on an airplane one at a time until your whole fleet is done.”
https://techxplore.com/news/2020-09-technology-safe-companies-scramble-covid-.html
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