FDA Antiviral Drugs Advisory Committee recommends approval for J&J hepatitis C drug
NEW YORK — A Food and Drug Administration expert panel has recommended approval for a drug made by Johnson & Johnson for treating hepatitis C, the company said.
J&J subsidiary Janssen Research & Development said the 19-member FDA Antiviral Drugs Advisory Committee voted unanimously to recommend approval for TMC435 (simeprevir), a 150-mg drug meant for administration once per day with the generic antiviral ribavirin and a biotech drug known as an interferon, for treating genotype 1 chronic hepatitis C.
"We are pleased with the positive recommendation from the advisory committee for simeprevir and appreciate the rigorous review of our data," Janssen medical department head for infectious diseases Katia Boven said. "It is our hope that the FDA will consider this recommendation and, upon completion of its review process, make simeprevir available to patients with genotype 1 chronic hepatitis C."
Catalina Health adds Safeway to its retail pharmacy network
ST. PETERSBURG, Fla. — Catalina Health on Thursday announced it will complete installation of all Safeway pharmacies into its retail pharmacy network at the end of November. Safeway will be utilizing Catalina Health pharmacy programs to disseminate information to their customers to encourage prescription medication adherence and compliance and advocate healthy lifestyles.
“The Catalina Health program is a wonderful complement to our existing pharmacy services,” said Darren Singer, SVP Safeway. “Educating our patients on the importance of taking their medication and making them aware of our preventive patient care and health services fits right in with Safeway’s strategy of becoming a health-and-wellness destination.”
“The Safeway philosophy aligns completely with our strategic vision and objectives of providing health consumers with the coordinated support they want and need to manage their health and wellness," stated Mark Doerr, Catalina SVP retail services.
Catalina Health develops and delivers relevant treatment-related messages to more than 130 million patients each year with precise, transaction-level insights.
FDA designates Merck hepatitis C drug as breakthrough therapy
WHITEHOUSE STATION, N.J. — The Food and Drug Administration has granted breakthrough therapy designation to an experimental drug made by Merck for hepatitis C, the drug maker said.
The agency gave the designation to MK-5172/MK-8742, a combination pill currently in mid-stage clinical development being investigated as a treatment for hepatitis C genotype 1. The FDA gives breakthrough therapy designation to expedite development and review of drugs planned for use in serious or life-threatening conditions when clinical trial evidence indicates it may represent a substantial improvement over existing therapies.
"There remains significant unmet medical need in hepatitis C, and we are looking forward to working with the FDA to advance this program as quickly as we can to bring this investigational combination to HCV specialists and their patients," Merck Research Labs president Roger Perlmutter said.