FDA declines approval for Rituxan, methotrexate combination
SOUTH SAN FRANCISCO, Calif. The Food and Drug Administration declined to approve an additional use of a rheumatoid arthritis drug while approving an update to its prescribing information, the drug’s manufacturers announced Monday.
Roche subsidiary Genentech and Biogen Idec said the FDA had given them a complete response letter for their approval application seeking additional use of the drug Rituxan (rituximab), for combining Rituxan with the generic drug methotrexate in patients with moderate to severe rheumatoid arthritis who no longer respond to treatment with disease-modifying antirheumatic drugs such as methotrexate alone.
At the same time, the FDA approved an update to Rituxan’s labeling to show how late-stage rheumatoid arthritis patients can be treated again with Rituxan if they have not responded well enough to drugs called tumor necrosis factor-antagonist therapies.
The FDA declined the approval application for Rituxan combined with methotrexate due to the rare risk of patients developing progressive multifocal leukoencephalopathy, a usually deadly brain infection caused by the JC virus. PML is rare in patients taking Rituxan, but Genentech also withdrew the psoriasis drug Raptiva (efalizumab) earlier this year after determining that the benefits of the drug did not outweigh the risks of patients developing PML.
Sandoz launches two products
PRINCETON, N.J. The generics arm of drug maker Novartis has launched two new products.
Sandoz announced the launch of topiramate sprinkle capsules, a generic version of Johnson & Johnson’s epilepsy drug Topamax Sprinkle, and calcium acetate capsules, an authorized generic of Fresenius Medical Care’s kidney failure drug PhosLo.
Topiramate capsules had sales of $56 million during the 12-month period ending in August, and PhosLo had sales of $42 million during the same period, according to IMS Health data.
FDA approves GSK’s HPV vaccine
PHILADELPHIA Merck & Co.’s highly successful human papillomavirus vaccine Gardasil has a new competitor.
The Food and Drug Administration approved GlaxoSmithKline’s Cervarix (human papillomavirus bivalent [types 16 and 18] vaccine, recombinant), for preventing infection by HPV – the virus that causes genital warts and can cause cervical cancer – in girls and women ages 10 to 25.
“The approval of Cervarix will bring an important new cervical cancer vaccine to girls and young women,” GSK president North American pharmaceuticals Deirdre Connelly said in a statement. “Immunization with a vaccine such as Cervarix – along with annual doctor visits and Pap tests – will help protect women from cervical cancer, the second leading cause of cancer death in women in their 20s and 30s.”
The FDA has already approved Merck’s Gardasil (human papillomavirus quadrivalent [types 6, 11, 16 and 18] vaccine, recombinant) for females and males ages 9 to 26.