FDA Advisory Committee Rejects Alzheimer's Drug

An FDA advisory committee rejected Biogen and Eisai’s aducanumab to treat Alzheimer’s disease, disagreeing with the FDA on the data. The FDA tried to convince the panel that a failed trial, with a positive post hoc subgroup analysis, is sufficient for approval, but the panel was not buying that argument. The FDA is expected to make a decision by March 7, 2021. This is a very detailed synposis of the virtual meeting.

FDA Advisory Committee on Alzheimer's Disease Drug -- Preview

The FDA’s Peripheral and Central Nervous System Drugs Advisory Committee is meeting virtually on November 6, 2020, to discuss the biologics license application for Biogen and Eisai’s aducanumab, an intravenous treatment to delay clinical decline in patients with Alzheimer’s disease (AD). The FDA reviewers were surprisingly positive about aducanumab, but the FDA staff were not all on the same positive page. So, it should be an interesting meeting.

Dry AMD Therapeutic Development Summit

After some very disappointing trials in dry AMD and GA, retina specialists are hoping that one or more of the treatments currently in development – complement inhibitors or cell therapies – will be successful, but there are questions about regulatory issues, trial endpoints, lack of validated biomarkers, the meaningfulness of efficacy levels being achieved, efficacy in Asian patients, long-term compliance, insurance coverage, and more.

Neuroblastoma Treatment Update

Two new potential therapies for high-risk neuroblastoma were highlighted at the International Society of Paediatric Oncology (SIOP) virtual conference, and both look promising: Y-mAbs Therapeutics’ Danyelza (naxitamab), an anti-GD2, and a GD2/GD3 vaccine from Y-mAbs. There were also positive data on managing the side effects of the current anti-GD2, United Therapeutics’ Unituxin (dinutuximab).

FDA Advisory Committee Meeting on Covid-19 Vaccine Development

It isn’t just the general public that is concerned about the FDA granting an emergency use authorization to a Covid-19 vaccine. Members of an FDA advisory committee also expressed concern about lack of diversity (in terms of both race and age) in the trials, the 2-month follow-up, the bar for showing efficacy, and more.

Heart Failure: Implantable Sensors

Studies presented at HFSA suggested a number of ways that implantable pulmonary artery sensors can benefit heart failure patients, including detecting pulmonary embolisms, improving metabolic syndrome, reducing repeat hospitalizations, and patient satisfaction. All of the data was on Abbott’s CardioMEMS, but a Phase III trial is underway with Endotronix’s Cordella.

European Respiratory Society

Late-breaking data was presented at ERS on three drugs for asthma: AB Science’s masitinib, a TKI; Novartis’ fevipiprant, an oral DP2 receptor antagonist; and Sanofi and Regeneron Pharmaceuticals’ Dupixent (dupilumab), an anti-IL-4/13. There was also data on a treatment nasal polyps. The dangers of light smoking and e-cigarettes were also highlighted.

Bulletin: Coronavirus Update 9/5

For the second time this year – and perhaps only the second time ever – the chief executive officers (CEOs) of five major pharmaceutical companies jointly held a press conference, sponsored and moderated by the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA), on Covid-19. The main focus was on therapeutics, though vaccines were also discussed by the heads of Gilead Sciences, Lilly, Merck MSD, Pfizer, and Roche.

Retina Report

There were positive data at the American Society of Retina Specialists virtual meeting on a number of drugs, including: Wet AMD: Roche’s PDS and faricimab, Kodiak Sciences’ KSI-301, and two gene therapies – Adverum Biotechnologies’ ADVM-022 and Regenexbio’s RGX-314; DME: Opthea’s OPT-302; Dry AMD: IVERIC bio’s Zimura and Hemera Biosciences’ gene therapy HMR-59; Retinitis pigmentosa: GenSight Biologics’ GS-030-DP and J&J’s AAV-RPGR gene therapy. But the news was not so good for Novartis’ Beovu. Doctors are reluctant to this longer-acting anti-VEGF due to safety issues.

TVT - LAA Closure

Interventional cardiologists are big fans of LAA closure for atrial fibrillation. In the U.S. only Boston Scientific’s Watchman is currently available, but cardiologists in Europe have a few others. European as well as U.S. cardiologists are anxious for newer devices – and there is a long list of them in development. Four sessions at the Transcatheter Valve Therapies virtual TVT 2020 provided a good overview and insight into how cardiologists are thinking about the new devices in development.

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