AstraZeneca has decided to withdraw its controversial anticoagulant Exanta (melagatran/ximelagatran) from the global market and terminate its development following adverse reports of liver damage in clinical trials patients. The drug is currently only dispensed in Europe after failing to win FDA approval in 2004 because of liver concerns. AstraZeneca estimates that approximately 400 patients are currently being prescribed the drug for short-term prevention of venous thromboembolism following orthopedic surgery. Two ongoing Exanta clinical trials will be discontinued and Exanta-treated patients switched to other treatments.
The FDA has approved Merck’s RotaTeq (rotavirus vaccine, live, oral, pentavalent) to prevent rotavirus gastroenteritis, a leading cause of severe diarrhea in infants and young children that kills nearly 500,000 children globally each year. Analysts forecast the vaccine could bring Merck as much as $500 million annually by 2009. RotaTeq is the second vaccine for rotavirus to be put on the market. The first, Wyeth’s RotaShield, was withdrawn just 10 months after it debuted in September 1998.
Genentech and Biogen Idec announced FDA approval of its jointly marketed Rituxan (rituximab) for use in the first-line treatment of patients with diffuse large B-cell, CD20-positive, non-Hodgkin's lymphoma (NHL), in combination with CHOP (cyclophosphamide, doxorubicin, vincristine and prednisone) or other anthracycline-based chemotherapy regimens. Rituxan has previously been approved as a single agent for use in relapsed or refractory, low-grade or follicular, CD20-positive, B-cell NHL. An estimated 360,000 Americans have NHL, and more than 58,000 new cases are diagnosed annually.
Merck said its New Drug Application (NDA) for Januvia (sitagliptin phosphate) for the treatment of type 2 diabetes has been accepted for standard review by the FDA. Merck expects FDA action on the NDA by mid-October and is moving forward as planned with filings in countries outside the United States.
The FDA issued a Public Health Advisory alerting doctors and patients that Bayer’s Trasylol (aprotinin injection), used to prevent blood loss during surgery, has been linked in two scientific publications to higher risks of serious side effects, including kidney problems, heart attacks and strokes in patients who undergo artery bypass graft surgery. “FDA is conducting a thorough evaluation of the safety profile for this drug in light of the recent publications,” said Steven Galson, director of the FDA’s Center for Drug Evaluation and Research. “We're working to evaluate the potential risks and determine whether there is a need for further action. In the meantime, we advise providers to carefully assess the benefits and risks of the drug for their patients.”
Bristol-Myers Squibb (BMS) is reported to have reached a deal to license its AIDS drug Reyataz to two generic drug manufacturers in the developing world free of charge, one of the first such agreements involving a second-line AIDS treatment. Under the deal BMS will grant a royalty-free license to South Africa’s Aspen Pharmacare Holdings and India’s Emcure Pharmaceuticals to make and sell atazanavir, the molecule Reyataz is based on, in sub-Saharan Africa. BMS received US marketing approval for Reyataz in 2003. The drug’s patent runs out in 2017.
The FDA may delay the March 1 start of a registry of patients using Roche’s acne treatment Accutane (isotretinoin) in an effort to keep pregnant women or those who may become pregnant from using the drug. An American Academy of Dermatology Association representative told the FDA and its drug advisory panel last Friday about glitches in entering patient data into the new registry and urged the FDA to delay the March 1 effective date.