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Monthly News Roundup - March 2016

FDA Approves Teva’s Cinqair to Treat Severe Asthma

In March, the U.S. Food and Drug Administration (FDA) approved Teva’s Cinqair (reslizumab) as an adjunct for the maintenance treatment of severe asthma in adults not well-controlled on their current asthma medications. Cinqair is an interleukin 5 (IL-5) antagonist monoclonal antibody (IgG4 kappa) given once every four weeks via infusion in a clinical setting. In studies, patients receiving Cinqair had fewer attacks, a longer time to first attack, and improvement in lung functions tests. Common side effects included anaphylaxis, cancer, and muscle pain. Nucala (mepolizumab) is GSK’s IL-5 antagonist also for severe asthma.

FDA Clears Lilly’s Taltz Injection for Plaque Psoriasis

Psoriasis is a chronic autoimmune disease in which skin cells are replaced at a quick rate leading to raised plaques that are flaky, red, and itchy. In March, FDA approved Eli Lilly's Taltz (ixekizumab) to treat adults with moderate-to-severe plaque psoriasis. Taltz is a humanized interleukin-17A antagonist. In pivotal clinical trials including over 3,800 patients, 87 to 90 percent of patients treated with Taltz saw a significant improvement in their condition at 12 weeks. Cosentyx (secukinumab) was the first IL-17 inhibitor, now approved for the treatment of plaque psoriasis, ankylosing spondylitis, and psoriatic arthritis.

Defitelio Approved for Life-Threatening Condition After Stem Cell Transplant

The FDA has approved Defitelio (defibrotide sodium) by Jazz Pharmaceuticals for the treatment of adults and children with hepatic veno-occlusive disease (VOD) with kidney or lung dysfunction following hematopoietic stem cell transplantation (HSCT). Defibrotide is a deoxyribonucleic acid derivative anticoagulant. In studies, patients with a diagnosis of hepatic VOD with multi-organ dysfunction after transplantation received defibrotide sodium until resolution of VOD. The Day +100 survival rates for Study 1, Study 2 and Study 3 were 38%, 44%, and 45% respectively. In comparison, looking at Day +100 historical control survival rates for patients who received supportive care or interventions other than defibrotide sodium ranged from 21% to 31%.

Spectrum’s Evomela Injection Approved for Multiple Myeloma

Evomela (melphalan) is an alkylating agent used in the treatment of patients with multiple myeloma (MM). MM is a malignancy of the plasma cells in the bone marrow, resulting in bone marrow failure and destruction. FDA has approved Evomela for use as a high-dose conditioning treatment prior to stem cell transplantation in patients with MM, and for the palliative treatment of patients with MM for whom oral therapy is not appropriate. This is the first product to be FDA-approved for the high-dose conditioning indication in MM. Evomela has also received Orphan Drug Designation. Evomela approval is the first new formulation of melphalan since 1964.

FDA Approves Gilead’s Odefsey for HIV-1 Infection Treatment

The U.S. Food and Drug Administration (FDA) has approved Odefsey (emtricitabine, rilpivirine and tenofovir alafenamide), a fixed-dose NNRTI and NRTI complete regimen for the treatment of HIV-1 infection. Odefsey is approved in patients 12 years and older who have no antiretroviral treatment history and HIV-1 RNA levels less than or equal to 100,000 copies per mL. Odefsey can also be used in patients on a stable antiretroviral regimen, no history of treatment failure, and no known substitutions due to resistance to any Odefsey components. Gilead’s Genvoya also contains the new tenofovir alafenamide, marked by fewer side effects and a lower dose than the original tenofovir.

Posted: March 2016