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Seven recent FDA actions involving dermatology
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Recent FDA developments related to dermatology included the agency granting priority review to cobimetinib combined with Zelboraf for advanced melanoma.
Other actions reported in Healio.com/Dermatology included the FDA agreeing to review a supplemental new drug application for Xeljanz for chronic plaque psoriasis and approving the VenaSeal closure system to permanently treat varicose veins of the legs.
1. FDA grants priority review to cobimetinib combined with Zelboraf for advanced melanoma
The FDA has granted priority review to cobimetinib in combination with vemurafenib for the treatment of patients with BRAF V600-positive advanced melanoma, according to a press release from the drug’s manufacturer.
“We are pleased the FDA has accepted our application for cobimetinib in combination with Zelboraf and granted it priority review status,” Sandra Horning, MD, chief medical officer and head of global product development at Genentech, said in a press release. Read more
2. FDA to review supplemental NDA for Xeljanz in adults with chronic plaque psoriasis
Pfizer announced that the FDA will review its supplemental new drug application for Xeljanz (tofacitinib citrate) 5-mg and 10-mg tablets for the treatment of adults with moderate-to-severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy. Read more
3. FDA approves VenaSeal system to permanently treat varicose veins
The FDA announced its approval of the VenaSeal closure system to permanently treat varicose veins of the legs by sealing the affected superficial veins using an adhesive agent.
The VenaSeal system is intended for patients with superficial varicose veins of the leg that cause symptoms such as pain, blood clots, skin ulcers or other problems, according to an FDA press release. Read more
4. FDA advisory committees to review talimogene laherparepvec for metastatic melanoma treatment
Amgen announced that the FDA’s Cellular, Tissue and Gene Therapies Advisory Committee and Oncologic Drugs Advisory Committee will jointly review the company’s biologics license application for talimogene laherparepvec for the treatment of patients with metastatic melanoma.
The committees will review talimogene laherparepvec, an investigational oncolytic immunotherapy designed to selectively replicate in tumors and initiate an immune response to metastasized cancer cells, on April 29. Read more
5. FDA accepts Actavis' supplemental NDA for Teflaro expanded labeling
Actavis announced that the FDA has accepted a supplemental new drug application for the label expansion of Teflaro for the treatment of concurrent bacteremia in patients with acute bacterial skin and skin structure infections caused by susceptible isolates of Staphyloccus aureus.
The application was based on data from the CANVAS 1 and 2 trials, in which Teflaro (ceftaroline-fosamil) monotherapy was compared with vancomycin plus aztreonam for the treatment of patients with acute bacterial skin and skin structure infection, according to a press release. Read more
6. FDA grants marketing authorization for direct-to-consumer genetic test for Bloom syndrome
The FDA authorized marketing of 23andMe’s Bloom Syndrome Carrier Status test, a direct-to-consumer genetic test that could determine whether a healthy person has the gene variant that could lead to offspring inheriting the disorder. Read more
7. FDA provides update on microbiological safety, cosmetics
Although injuries from contaminated cosmetics are not common, they can be serious, according to a cosmetic safety update from the FDA.
The update included information on how microorganisms can contaminate cosmetics, ways consumers can protect themselves against microbial contamination and efforts the FDA is utilizing to minimize cosmetic contamination. Read more