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.
BioRx launches hemophilia smartphone app
CINCINNATI — A mobile app described as the specialty pharmacy industry’s first for patients with hemophilia has become available.
Specialty pharmacy and infusion services provider BioRx announced the launch of the app, MyFactor, which it developed to give patients with hemophilia and related bleeding disorders and their caregivers a place to easily monitor and manage their home treatment. The app will be released in the Apple Store next month and allows patients to electronically record bleeding episodes and treatments and share information with their healthcare team, including pharmacists, physicians, nurses and care coordinators.
"MyFactor is the first hemophilia app from a specialty pharmacy," BioRx co-founder Eric Hill said. "This creates a unique platform for BioRx customers and staff to more efficiently communicate and exchange detailed treatment information and helps both parties to anticipate and plan for future needs."
Patients and caregivers can use a "wizard" graphical interface to log details of treatments and bleeding episodes, including type, cause, location and levels of pain and severity, as well as scan barcodes of clotting factor brands and generate customized historical reports in formats like PDF and CSV.
Clinical trial results support experimental Gilead drug for hepatitis C as safe, effective, FDA records show
NEW YORK — An experimental drug under development by Gilead Sciences for hepatitis C is safe and effective when combined with other treatments, according to a review posted on the Food and Drug Administration’s website ahead of an expert panel meeting to take place Friday.
The FDA’s Antiviral Drugs Advisory Committee will meet Friday to decide whether or not to recommend approval for sofosbuvir combined with the generic antiviral ribavirin or biotech drugs used to treat hepatitis C called interferons. Gilead is seeking FDA approval for the drug in treating patients with hepatitis C genotypes 1-4. Advisory committee votes do not guarantee whether the FDA will approve a drug, but the agency usually follows them.
According to the review, a combination of sofosbuvir with ribavirin in patients with genotypes 2 and 3 of the virus would provide the treatment consisting entirely of orally administered drugs, without interferons, as well as shorter treatment times and better safety than treatments including interferons. While effective in treating and curing hepatitis C, interferons have many side effects, including severe depression.
In addition, the review said the drug would be more effective and faster in patients with genotypes 1 and 4 when combined with interferons and ribavirin.