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Weekly Drug News Round-Up: March 29, 2017

Ocrevus Approved for Novel Use Among Multiple Sclerosis Treatments

Ocrevus is administered by intravenous infusion every six months Read More…

The much anticipated multiple sclerosis (MS) treatment Ocrevus (ocrelizumab) was finally given the green light this week from the FDA. Ocrevus is a humanized monoclonal antibody designed to selectively target CD20-positive B cells. It is the first treatment approved for primary progressive multiple sclerosis (PPMS), but it is also indicated for relapsing (RMS). In both forms of MS, Phase III clinical studies showed that Ocrevus slowed disability progression and reduce signs of disease activity in the brain (MRI lesions). In the RMS group, relapses per year were reduced by nearly one-half. Side effects were primarily mild to moderate in severity and rates were similar to high-dose interferon beta-1a or placebo groups; these included infusion reactions and upper respiratory tract infections. Genenetech says Ocrevus will be available in the U.S. within two weeks.

Dupixent Cleared for More Advanced Eczema

Dupixent can be used with or without topical corticosteroids Read More...

Eczema is also known as atopic dermatitis, a chronic inflammatory skin disease resulting in red, scaly, crusty and itchy bumps. This week the FDA cleared Regeneron’s Dupixent (dupilumab) injection to treat adults with moderate-to-severe eczema who cannot use or have inadequate results with topical therapies. Clinical trials evaluating safety and effectiveness of Dupixent in over 2,100 adults with moderate-to-severe atopic dermatitis revealed a greater response, defined as clear or almost clear skin as compared to placebo, with a reduction in itching, after 16 weeks of therapy.

FDA Grants Approval of Bavencio for Rare Merkel Cell Skin Cancer

Bavencio is the first FDA-approved treatment for metastatic MCC Read More...

Bavencio (avelumab), a programmed death ligand-1 (PD-L1) blocking antibody, received accelerated FDA-approval for the treatment of patients 12 years and older with metastatic Merkel cell carcinoma (MCC). MCC is rare form of skin cancer that often occurs on the face, head or neck and can recur after surgical removal. Approval of Bavencio was based on a study of 88 patients with metastatic MCC who had previously received chemotherapy. Partial or full tumor shrinkage occurred in 33% of patients, lasting for more than 6 and 12 months in 86% and 45% of patients, respectively. Common side effects include fatigue, muscle pain, diarrhea, nausea, infusion-related reactions, and rash, among others.

Symproic Okayed for Treatment of Opioid-Induced Constipation

Constipation is one of the most commonly reported side effects associated with opioid treatment Read More...

This week the FDA approved Shionogi’s and Purdue Pharma’s Symproic (naldemedine), a peripherally-acting mu-opioid receptor antagonist for the treatment of opioid-induced constipation (OIC). Symproic approval was based on data from the  COMPOSE randomized trials: two 12-week efficacy studies and one 52-week safety study conducted in adult patients with OIC and chronic non-cancer pain. Symproic is currently a Schedule II controlled substance, but the manufacturer has asked the DEA to review to possibly remove scheduling. Symproic is expected to be commercially available mid-summer.

Zejula FDA-Approved for Multiple Recurrent Cancers in Women

Zejula will be made available in the U.S. in late April Read More...

The FDA has approved Zejula (niraparib) for the maintenance treatment of women with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer following response to platinum-based chemotherapy. Zejula is an oral, once-daily poly(ADP-ribose) polymerase (PARP) inhibitor and the first PARP inhibitor that does not require BRCA mutation or other biomarker testing. In pivotal clinical studies in patients with a germline BRCA mutation, the median progression-free survival (PFS) was 21 months, compared to 5.5 months for the control group, a significant result. In the group without a BRCA mutation, median PFS was 9.3 months compared with 3.9 months in patients in the placebo group.