Genentech, Biogen Idec receive complete response for cancer drug application
SOUTH SAN FRANCISCO, Calif. The Food and Drug Administration has turned down a request by two biotech companies seeking approval for a drug as a treatment for chronic lymphocytic leukemia.
Biogen Idec and Genentech, now part of Switzerland-based Roche Group, announced that the FDA had given them a complete response letter – a notification that the agency is not ready to grant approval – for their application for Rituxan (rituximab) combined with the chemotherapy drug fludarabine, originally made by Genzyme and now available as a generic, and Baxter’s Cytoxan (cyclophosphamide) as a treatment for people with CLL.
The two companies said they were “committed” to winning approval for the three-drug combination as a CLL treatment, though the FDA did not request any new data in its letter.
FDA approves Qutenza
ROCKVILLE, Md. A substance familiar to diners at Mexican and Sichuan Chinese restaurants also is the active ingredient in a newly approved drug for treating pain resulting from shingles.
The Food and Drug Administration announced Tuesday the approval of Qutenza, a patch made by Andernach, Germany-based Lohmann Therapy Systems. The patch uses capsaicin, the compound that gives chili peppers their bite, to treat pain from postherpetic neuralgia. PHN occurs in more than 10% of patients who have had shingles, an outbreak of rash and blisters on the skin caused by the varicella-zoster virus, the same virus that causes chickenpox.
The FDA said Qutenza was the first pure, concentrated, synthetic capsaicin-containing prescription drug to undergo review by the agency, having gained approval Monday.
“This new product can provide effective pain relief for patients who suffer from PHN,” FDA Center for Drug Evaluation and Research Division of Anesthesia, Analgesia and Rheumatology Products director Bob Rappaport said in a statement.
Pfizer seeks to develop tropical disease treatments
GENEVA The world’s largest drug maker plans to tackle rare tropical diseases.
Pfizer announced Wednesday a partnership with Drugs for Neglected Diseases Initiative under which the two will develop drugs to treat human African trypanosomiasis, visceral leishmaniasis and Chagas disease.
Those names may sound unfamiliar to people in North America, but they have devastating effects on people in developing countries. Chagas disease, for example, results from infection by a protozoan parasite spread by the kissing bug, a relative of the assassin bugs and stink bugs common in American gardens that feeds on people’s blood while they sleep. The parasite infects the heart and can cause death unless the patient receives multiple heart transplants over the course of his or her life.
“Despite considerable progress made in recent years, these three diseases continue to take a terrible human toll and represent a significant social burden for developing countries,” Pfizer Global Research & Development chief scientific officer for antivirals and VP Manos Perros said in a statement. “We are expanding our commitment to the fight against tropical diseases by joining forces with DNDi by sharing our collection of chemical compounds and the knowledge and expertise associated with these chemical entities.”
DNDi will have access to a library of 150,000 compounds that it will test against the three diseases, seeking compounds that work against the parasites. DNDi scientists will conduct the tests for human African trypanosomiasis at the Eskitis Institute for Cell and Molecular Therapies at Griffith University in Brisbane, Australia, while tests for the other two diseases will take place at the Institut Pasteur Korea.