Most (54%) respondents indicated that they believe the FDA made a mistake when it approved the controversial Alzheimer’s drug in June 2021.
The dust still hasn’t settled on the FDA’s controversial decision last year to approve Biogen’s Alzheimer’s drug, Aduhelm (aducanumab). Last week CMS announced that it is proposing to cover the drug only if the patient is enrolled in an approved clinical trial, a move that seems to reflect concern the FDA’s OK was based on shaky evidence. Biogen fired off a press release said if the Jan. 11 coverage decision doesn’t change, nearly all Medicare beneficiaries will be denied access to its drug. Biogen had already tried to blunt some of the criticism of its anti-amyloid drug by slashing its price in half, from $56,000 a year, on average, to $28,200.
Related: 5 Things You Should Know About the Aduhelm Price Cut
Most of the respondents to our annual State of the Industry are in the skeptical/critical camp when it comes to Aduhelm: 54% indicated that they believed it was a mistake for the FDA to approve the drug. The survey had 100 respondents, although not every respondent answered all the questions.
Aduhelm was approved on the FDA’s accelerated pathway, which, among other things, means a drug will be judged by the agency on its effects on surrogate markers for management or control of a disease rather than on manifestations of the disease itself. The solid majority believes the Aduhelm approval was a misstep but an even larger majority (74%) of the respondents indicated that they didn’t think the FDA has approved too many drugs through the accelerated approval process.
Medicare Patients with PAH Face High Out-of-Pocket Costs | 2024 ATS
May 19th 2024Medicare patients who have pulmonary arterial hypertension and who are eligible for the low-income subsidy often have advanced disease, require prolonged disability insurance and face financial hardships, according to a poster at the annual ATS meeting.
Read More
FDA Updates for Week of May 13: First Bispecific Antibody for Solid Tumor
May 18th 2024The FDA has approved a new type of bispecific antibody to treat small cell lung cancer and an additional indication for Breyanzi for patients with follicular lymphoma. The agency has set review date for gene therapy for enzyme deficiency. In addition, Biogen have Eisai hve begun a rolling submission of subcutaneous Leqembi for Alzheimer’s disease.
Read More