Genzyme reports lackluster results in MS drug trial
CAMBRIDGE, Mass. — An orally administered drug made by Genzyme for treating multiple sclerosis did not appear superior to a biotech drug already on the market, according to results of a late-stage clinical trial.
Genzyme, owned by French drug maker Sanofi, compared the once-daily drug teriflunomide with Rebif (interferon beta-1a), made by Pfizer and Merck KGaA, in patients with relapsing MS in the 324-patient "TENERE" trial. Merck KGaA, based in Germany, operates under the name EMD Serono in the United States to avoid confusion with U.S.-based Merck & Co.
Teriflunomide in doses of 7 mg and 14 mg did not show superiority over Rebif on risk of treatment failure, defined as a disease relapse or permanent discontinuation of treatment for any reason. Among patients receiving the 7-mg dose, 48.6% did not show risk of treatment failure, compared with 37.8% of those taking the 14-mg dose, and 42.3% of those taking Rebif.
Estimated annual relapse rates were higher among patients taking teriflunomide in the 7-mg dose than among those taking the 14-mg dose or Rebif, while patients taking Rebif showed higher rates of permanent treatment discontinuation than those taking teriflunomide.
Merck’s Isentress approved for children, adolescents
SILVER SPRING, Md. — The Food and Drug Administration has approved an HIV drug for children and adolescents, the agency said Wednesday.
The FDA announced the approval of Merck’s Isentress (raltegravir) for HIV-1 infection in patients ages 2 to 18 years. The chewable form of the drug will be available for children ages 2 to 11 years.
"Many young children and adolescents are living with HIV, and this approval provides an important additional option for their treatment," FDA Office of Antimicrobial Products director Edward Cox said.
Ranbaxy settles cGMP issues with U.S. government
GURGAON, India — Ranbaxy Labs said Wednesday that it had resolved long-standing issues concerning two of its manufacturing plants in India with the U.S. government.
The generic drug maker said it had signed a consent decree with the Food and Drug Administration, subject to the approval of the U.S. District Court for the District of Maryland, with the intent to ensure data integrity and comply with current good manufacturing practices. Ranbaxy, which Japanese drug maker Daiichi Sankyo took control of in 2008, also is paying $500 million to the Department of Justice, which was investigating the matter.
"We are pleased to have resolved this legacy issue with the FDA as we begin the next chapter in Ranbaxy’s history," Ranbaxy CEO and managing director Arun Sawhney said. "While we were disappointed by the conduct that led to the FDA’s investigation, we are proud of the systematic corrective steps we have taken to upgrade and enhance the quality of our business and manufacturing processes."
In September 2008, the FDA barred importation of 30 drugs made in Ranbaxy’s plants in Dewas and Paonta Sahib, India, due to cGMP violations found during routine inspections. It was long speculated that the FDA’s actions would jeopardize the drug maker’s planned launch of a generic version of Pfizer’s cholesterol drug Lipitor (atorvastatin calcium), but a resolution of the cGMP problems with the FDA allowed Ranbaxy to launch on Nov. 30, as scheduled.