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Monthly News Roundup - December 2016

Biogen’s Spinraza Approved for Spinal Muscular Atrophy

The U.S. Food and Drug Administration (FDA) has cleared Biogen's Spinraza (nusinersen), the first drug for spinal muscular atrophy (SMA), a rare and often fatal genetic disease affecting muscle strength and movement. Spinraza is classified as a survival motor neuron-2 (SMN2)-directed antisense oligonucleotide and alters the splicing of the SMN2 gene to yield a more functional protein. In an interim analysis of efficacy, 40% of patients treated with Spinraza achieved improvement in motor milestones such as sitting, standing and walking, while no control patients met milestones. Common side effects include respiratory infection and constipation.

Rubraca Gets Early Accelerated Approval for Ovarian Cancer

In an end-of-year approval, the U.S. Food and Drug Administration (FDA) has cleared Clovis Oncology's Rubraca (rucaparib) over 2 months early for the treatment of advanced mutant BRCA ovarian cancer. Rubraca is for women who have been treated with two or more chemotherapies and who have a specific BRCA gene mutation. Rubraca, a poly (ADP-ribose) polymerase (PARP) inhibitor, blocks an enzyme involved in repairing damaged DNA inside the cancerous cells with BRCA genes. In studies, 54% of patients who received Rubraca experienced complete or partial shrinkage of their tumors lasting a median of 9.2 months. Common side effects include nausea, fatigue, and vomiting.

Eucrisa Can Now Be Marketed for Use in Eczema

FDA has approved Anacor’s Eucrisa (crisaborole) ointment to treat mild to moderate eczema (atopic dermatitis) in patients two years of age and older. In atopic dermatitis, the skin develops red, scaly and crusted bumps which are extremely itchy and may lead to thickening of the skin. Eucrisa, applied topically twice daily, is a nonsteroidal phosphodiesterase 4 (PDE-4) inhibitor. In studies, participants receiving Eucrisa achieved greater response with clear or almost clear skin after 28 days of treatment. The most common side effect of Eucrisa is application site pain; serious side effects include allergic reactions to the active ingredient.

Jardiance Shown to Reduce Cardiovascular Death in Type 2 Diabetes

The FDA has approved a new indication for Jardiance (empagliflozin) to reduce the risk of cardiovascular death in adult patients with type 2 diabetes and heart disease. Jardiance, from Boehringer Ingelheim, is a sodium glucose co-transporter-2 (SGLT2) inhibitor and was originally approved in 2014 to improve blood sugar control in adults with type 2 diabetes alongside diet and exercise. For the new indication, Jardiance was studied in a Phase 4 study of over 7,000 patients and was shown to reduce the risk of cardiovascular death compared to a placebo when added to standard of care diabetes therapies.

FDA Clears Avastin Plus Chemotherapy for Platinum-Sensitive Ovarian Cancer

The FDA has approved Genentech's Avastin (bevacizumab), used with carboplatin and paclitaxel, or carboplatin and gemcitabine chemotherapy, followed by Avastin alone, for the treatment of patients with platinum-sensitive recurrent epithelial ovarian cancer, fallopian tube or primary peritoneal cancer. In clinical trials, adding Avastin to chemotherapy showed an overall survival difference of five months compared to chemotherapy alone, and a significant improvement in progression-free survival. However, overall survival, a secondary endpoint, was not significantly improved with the addition of Avastin to chemotherapy. Avastin is also approved for platinum-resistant recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer.

Posted: December 2016


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