Vertex’s hepatitis C drug granted priority review by FDA, Health Canada
CAMBRIDGE, Mass. — The Food and Drug Administration and Health Canada have granted priority review to a drug for treating hepatitis C.
Vertex Pharmaceuticals announced Thursday that the two agencies had given the designation to telaprevir for treating patients with chronic infections.
The FDA grants priority review to medicines that it determines to offer major advances in treatment or provide a treatment where no adequate therapy exists; standard review time is 10 months, but priority review reduces it to six, meaning the agency plans to finish its review by May 23. In Canada, standard review time is 18 months, and priority review reduces it to between six and nine.
“Data from phase-3 studies showed that when compared to currently available medicines, telaprevir-based combination therapy nearly doubled viral cure rates and cut treatment time in half for the majority of patients new to treatment,” said Peter Mueller, Vertex chief scientific officer and EVP global research and development. “We look forward to working with the FDA and Health Canada to make telaprevir available as quickly as possible for people with hepatitis C.”
ProStrakan taps two companies to administer REMS program for Abstral
ATLANTA — British drug maker ProStrakan Group will partner with two U.S. companies to administer its risk evaluation and mitigation strategy for a cancer pain drug.
ProStrakan said it would use RelayHealth Pharmacy Solutions’ and McKesson Specialty Care Solutions’ services to administer the REMS for Abstral (fentanyl citrate), a drug that patients can place under the tongue to treat breakthrough pain associated with cancer when they already have received and become tolerant of opioid painkillers.
“RelayHealth’s innovative connectivity technologies in pharmacies and McKesson Specialty Care Solutions’ deep REMS experience is an excellent fit for our Abstral REMS program,” ProStrakan president for global commercial operations Abid Karim said.
Dey Pharma launches MyEpiPen app
BASKING RIDGE, N.J. — Mylan subsidiary Dey Pharma has launched a mobile application for patients at risk of severe allergic reactions, which is tied to its EpiPen product.
The MyEpiPen app is available for the Apple iPhone, iPod Touch and iPad, and allows individuals, parents, guardians and others to create and share profiles of severe allergies with friends, family, teachers, school nurses, babysitters and others. Other features include an instructional video, user guide and others.
“Mylan and Dey Pharma have been steadfast in our long-standing commitment to meeting unmet needs,” Dey COO Lloyd Sanders said. “Toward that effort, we are very excited about the MyEpiPen apps, as they will provide a portable and accessible tool to equip individuals and caregivers with valuable information they may need to care for themselves and others in the event of an allergic emergency.”