FDA Actions
November 1, 2014
The FDA has approved the first combination pill to treat patients with hepatitis C virus (HCV) genotype 1 infection. The new product contains the previously approved blockbuster sofosbuvir (Sovaldi) along with the newly approved ledipasvir. This is the first combination for the treatment of HCV genotype 1 that does not require administration with interferon or ribavirin, drugs that have significant side effects for many patients. The new combination was approved on the basis of three clinical trials of more than 1500 patients in which sustained virologic response was 94-99%, depending on the clinical setting. The drug was approved under a priority review and was designated a breakthrough therapy. Common side effects include fatigue and headache. Sofosbuvir/ledipasvir is marketed by Gilead Sciences as Harvoni. The drug is taken for 12 weeks for most patients, although treatment-experienced patients with cirrhosis require 24 weeks of therapy. The cost for 12 weeks is roughly $95,000.
As reported last month, the manufacturers of varenicline (Chantix) petitioned the FDA remove the black box warning on the drug that warns of neuropsychiatric side effects. The petition was initiated after new research suggested no increase in neuropsychiatric risks. The FDA, however, has recently elected to turn down the petition and maintain the black box warning suggesting that new research does not include all possible psychological effects. Pfizer, the drug’s manufacturer, is currently doing a study on 8000 patients that compares neuropsychiatric outcomes associated with varenicline with two other smoking cessation products as well as placebo.
The FDA has approved a new combination drug for the treatment of nausea and vomiting in patients undergoing cancer chemotherapy. The oral agent combines netupitant, a newly approved NK1 receptor antagonist, along with the previously approved 5-HT3 receptor antagonist palonosetron. The combination prevents acute phase nausea (palonosetron) and delayed phase nausea (netupitant) after starting chemotherapy. Approval was based on two trials of more than 1700 cancer patients in which the drug was effective in preventing vomiting in the acute, delayed, and overall phases after the start of chemotherapy. The combination is marketed by Eisai Inc. as Akynzeo.
The FDA has approved two new drugs for the treatment of idiopathic pulmonary fibrosis. Pirfenidone acts on multiple pathways involved in scarring of lung tissue while nintedanib is a kinase inhibitor that also prevents scarring of lung tissue. Both drugs were approved under priority review as orphan products and designated as breakthrough therapy. Pirfenidone is marketed by InterMune Inc. and Roche as Esbriet and nintedanib is distributed by Boehringer Ingelheim as Ofev. Both drugs are expected to cost about $95,000 per year.
You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
- Award-winning Medical Content
- Latest Advances & Development in Medicine
- Unbiased Content