FDA Advisory Committee update
FDA's Psychopharmacologic Drugs Advisory Committee voted unanimously on October 25 that long-term efficacy studies for antidepressants should not be required prior to approval.
FDA's Psychopharmacologic Drugs Advisory Committee voted unanimously on October 25 that long-term efficacy studies for antidepressants should not be required prior to approval.
Committee members stated that long-term efficacy data are needed for antidepressants but not necessary prior to approval. The studies should be conducted as soon as possible, according to the panel, possibly by at least initiating the trials or having FDA approve trial design prior to approval of the drug. Other committee members commented that long-term safety studies, not efficacy studies, should be of primary concern to FDA.
Source FDC Reports. Antidepressant long-term studies prior to approval should not be required, cmte. says. Available at: http:// http://www.fdaadvisorycommittee.com/. Accessed November 4, 2005.
FDA Approves Two More Denosumab Biosimilars, Conexxence and Bomyntra
March 27th 2025The fourth pair of denosumab biosimilars, Conexxence and Bomyntra, are expected to launch in the United States in mid 2025, as a result of a global settlement with Amgen, according to a company news release.
Read More
FDA Approves First Drug for Excess Hunger in Prader-Willi Syndrome
March 27th 2025Vykat XR will be available in April to treat the intense hunger that is a hallmark of the rare genetic disease Prader-Willi syndrome. The price is based on a patient’s weight, and the average patient in the clinical trials would have had an average annual cost of $466,200 for the first year.
Read More
FDA Approves Amvuttra for ATTR-CM in Extended Label
March 21st 2025This expanded indication for Amvuttra makes it the first and only FDA-approved treatment for transthyretin amyloidosis with cardiomyopathy (ATTR-CM) and the polyneuropathy of hereditary transthyretin-mediated amyloidosis (hATTR-PN) in adults.
Read More
