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Monthly News Roundup - February 2016

Briviact Wins FDA Approval As Adjunct for Partial Onset Seizures

Epilepsy is a brain disorder that causes people to have recurring seizures, consisting of uncontrollable muscle movements, abnormal sensations or thinking. The U.S. Food and Drug Administration (FDA) has approved Briviact (brivaracetam) as an add-on treatment for partial onset seizures in patients age 16 years and older with epilepsy. Briviact (brivaracetam) is a selective, high-affinity synaptic vesicle protein 2A ligand and analog of levetiracetam. In clinical trials involving 1,550 participants, Briviact was shown effective as an adjunct to reduce seizure activity, with common side effects including drowsiness, dizziness, fatigue, nausea and vomiting.

Pfizer’s Xeljanz XR Once-Daily Approved for Rheumatoid Arthritis

Rheumatoid arthritis (RA) is a chronic, inflammatory autoimmune disease that leads to pain and swelling in the joints, often of the hands, feet and knees. In February, FDA approved Pfizer’s Xeljanz XR (tofacitinib citrate) extended-release 11 mg tablets for the once-daily treatment of moderate to severe rheumatoid arthritis (RA) in patients who have had an inadequate response or intolerance to methotrexate (MTX). Xeljanz XR is the first once-daily oral RA drug for adults in the Janus kinase (JAK) inhibitor class. Originally, Xeljanz was approved in 2012 as a 5 mg tablet taken twice a day for RA.

Halaven Approved and Extends Survival Time in Liposarcoma

Liposarcoma is a rare malignant tumor that develops from fat cells in deep soft tissue. The tumors are most commonly found in the abdomen and limbs. The FDA has approved Halaven (eribulin mesylate), a microtubule inhibitor, for the treatment of liposarcoma that cannot be removed by surgery or is advanced. Halaven is used for patients who received prior chemotherapy that contained an anthracycline drug. The clinical trial data indicates that Halaven increased overall survival by about seven months. Common side effects in trials were fatigue, nausea, hair loss (alopecia), constipation, and peripheral neuropathy.

FDA Expands Breast Cancer Indication for Pfizer’s Ibrance

Ibrance (palbociclib) is a first-in-class cyclin-dependent kinase 4/6 (CDK 4/6) inhibitor approved by the FDA for advanced breast cancer. Ibrance is now approved in HR+, HER2- metastatic disease in combination with fulvestrant in women with disease progression following endocrine therapy, regardless of menopausal status. In the Phase 3 PALOMA-3 trial, 521 women were enrolled to receive Ibrance plus fulvestrant or placebo plus fulvestrant. In the Ibrance plus fulvestrant arm, progression-free survival (PFS) was statistically significant at a median of 9.5 months compared to 4.6 months in the fulvestrant/placebo group.

FDA Approves Merck’s Once-Daily Zepatier for Hepatitis C

Hepatitis C virus (HCV) affects over 3 millions Americans, and may lead to liver impairment, cirrhosis or even liver failure. Late last month the FDA approved the oral treatment Zepatier (elbasvir and grazoprevir) with or without ribavirin for the treatment of chronic hepatitis C virus (HCV) genotypes 1 (the most common) and 4 (the least common) in adults. In clinical trials, cure rates (SVR12) ranged from 94 to 97 percent in genotype 1 and from 97 to 100 percent in genotype 4-infected subjects. Common side effects included headache, nausea, and fatigue.

Posted: February 2016