The FDA has issued a Drug Safety Communication regarding a case of progressive multifocal leukoencephalopathy (PML) in a patient who was taking fingolimod (Gilenya) for the treatment of multiple sclerosis. This is the first reported case of PML associated with fingolimod in patients who had not previously taken natalizumab (Tysabri). The patient, who lives in Europe, had been on the drug for about 8 months and had previously taken interferon beta-1a, azathioprine, and steroids. Novartis, the manufacturer of fingolimod, indicated it is possible that the patient had PML prior to starting the drug. PML is a rare neurologic disease caused by latent infection with the JC virus. It has been associated with immunosuppressive drugs, including natalizumab.
The FDA has approved a new topical agent to treat facial redness in adults with rosacea. Brimonidine, an alpha-2 agonist, is currently used as an ophthalmic preparation for treating glaucoma. The drug constricts dilated facial blood vessels for up to 12 hours. It is approved in a 0.33% topical gel that is applied once daily. Patients with depression, coronary artery disease, Raynaud’s, or other conditions that may be exacerbated by an alpha agonist should use the drug with caution. Brimonidine gel is marketed by Galderma as Mirvaso.
The FDA has approved dolutegravir, a new once-daily HIV integrase inhibitor. It is the third integrase inhibitor on the market after raltegravir and elvitegravir. The drug is indicated for use in combination with other antiretroviral agents for the treatment of HIV-1 infections in adults and children ≥ 12 years of age weighing at least 40 kg. It may be used in treatment-naïve patients or treatment-experienced patients, including those who have previously taken an integrase inhibitor. Approval was based on four trials in more than 2500 patients that showed efficacy in combination with other antiretrovirals. A fifth trial showed efficacy in HIV-infected children as young as 12 who had not taken an integrase inhibitor. Dolutegravir is marketed by ViiV Healthcare as Tivicay.