A European approval for Alzheimer’s drug aducanumab by year-end looks even more in doubt. A week after being called in before the EMA’s Committee for Medicinal Products for Human Use (CHMP) for an oral explanation of the trial data, Biogen Inc. said it received a “negative trend vote” on the marketing authorization application. A formal opinion by the CHMP is expected at its December meeting, but analysts are not optimistic.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Basilea, Biogen, Crispr, Coya, Cyclo, Cytodyn, Diurnal, Icure, Moderna, Mymd, Siga, Viacyte.
Celltrion Inc.’s Regkirona (regdanvimab), a monoclonal antibody treatment for COVID-19, received its latest approval from the European Commission (EC), making it the first Mab developed in South Korea to be approved there. The green light for Celltrion Healthcare Hungary Kft., the Hungarian arm of Korean biopharmaceutical company Celltrion, is for the treatment of adults with COVID-19 aged 18 and over who do not require supplemental oxygen and who are also at increased risk of severe disease.
A busy regulatory environment globally throughout most of 2021 has translated into more than 15% of all actions taken relating to the COVID-19 pandemic, yet only one product has been approved in the U.S. for the SARS-CoV-2 virus.
The FDA has approved Pharmaessentia Corp.'s Besremi (ropeginterferon alfa-2b) for the rare blood disorder polycythemia vera, the interferon offering an alternative to JAK inhibitor therapy. PV is a rare, chronic and life-threatening blood cancer caused by a mutation in stem cells in the bone marrow, resulting in overproduction of blood cells. Besremi, which is already approved in Taiwan, Europe and South Korea, is a monopegylated, long-acting interferon, which counteracts the effects of the mutated bone marrow cells and is initially taken fortnightly.
U.S. President Joe Biden on Nov. 12 announced his intent to nominate former FDA Commissioner Robert Califf to return to the regulator’s top job. He would take the place of Janet Woodcock, acting commissioner of the agency since Jan. 20.
Technically speaking, the scientific community as a whole cannot say for sure whether and how well Aduhelm (aducanumab, Biogen Inc./Eisai, Co., Ltd.) works. After all, two years after the initial report of the Engage and Emerge data at the 2019 Clinical Trials in Alzheimer’s Disease (CTAD), the full trial data have still not been published in a peer-reviewed publication. Which, of course, is one of the problems with Aduhelm.
European regulators have put off a decision on Biogen Inc and Eisai, Co. Ltd.’s controversial Alzheimer’s drug, aducanumab, for likely another month, after the companies announced further supportive data from a follow-up under review by the FDA.
The FDA has taken a hands-off approach to general wellness products that take up residence in smartphones, but that doesn’t mean these products aren’t subject to regulatory drift.
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