Vemlidy Approved for Hepatitis B
November 10, 2016 – The US FDA approved Vemlidy® (tenofovir alafenamide) manufactured by Gilead Sciences, Inc. Vemlidy is indicated to treat patients who have chronic hepatitis B and compensated (not yet progressed to cirrhosis) liver disease. Vemlidy maintains relatively constant blood levels, therefore it is effective at a lower dose (25mg/day) than Gilead’s previous hepatitis B drug, Viread® (tenofovir disoproxil fumarate), which is dosed at 300mg/day. As a result, Vemlidy does not cause as many side effects, particularly on bones and in kidneys, as Viread does. Labeling for Vemlidy does include a boxed warning that taking it may be associated with two potentially serious conditions -- lactic acidosis (excessive lactate accumulation) and hepatomegaly with steatosis (enlargement of the liver with fat deposits). In addition, hepatitis B may reactivate after treatment with Vemlidy ends. Recommended dosing is one tablet daily along with a meal or snack. Vemlidy will be launched through open distribution on Nov. 11, 2016, with a wholesale price of approximately $1,000 for a 30-day supply, which is comparable to Viread.
Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by regular mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Actual drug patent expiration dates and availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.