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Weekly Drug News Round-Up: May 24, 2017

IL-6 Antagonist Kevzara Cleared to Treat Rheumatoid Arthritis (RA)

IL-6 is a cytokine that can contribute to the inflammation and pain associated with RA Read More...

Kevzara (sarilumab), from Regeneron and Sanofi, is an interleukin-6 receptor (IL-6R) antagonist newly approved for the treatment of patients with moderate-to-severe rheumatoid arthritis who have had an inadequate response or cannot tolerate one or more disease-modifying antirheumatic drugs (DMARDs). Kevzara may be used as monotherapy or in combination with methotrexate (MTX) or other conventional DMARDs. In studies, the most common side effects included neutropenia, increased liver enzymes, injection site redness, upper respiratory infections and urinary tract infections. In the MOBILITY study, treatment with Kevzara plus MTX reduced signs and symptoms, improved physical function, and demonstrated significantly less radiographic progression of structural damage, compared to placebo plus MTX.

Actemra: First Drug Approved to Treat Giant Cell Arteritis

Previously, these patients had limited treatment options Read More…

Actemra (tocilizumab) from Hoffman La Roche has gained a new labeled indication - it is the first drug approved to treat adults with giant cell arteritis, a specific type of vasculitis. Vasculitis is a group of disorders that leads to swelling of blood vessels. In a clinical study of 251 patients with giant cell arteritis, the primary endpoint - the proportion of patients achieving sustained remission from Week 12 through 52 - was met. Sustained remission included absence of symptoms, normalization of inflammatory laboratory tests, and tapered use of prednisone. More patients receiving Actemra plus prednisone achieved sustained remission compared to patients receiving placebo plus prednisone.

Merck’s Keytruda Wins Nod for Advanced Urothelial Bladder Cancer

Keytruda is in over 500 clinical trials involving more than 30 tumor types Read More...

Merck’s anti-PD-1 immunotherapy Keytruda (pembrolizumab) has been FDA-approved for certain patients with locally advanced or metastatic urothelial carcinoma, a type of bladder cancer. There are 2 new indications: Keytruda can be used first line for patients who are ineligible for cisplatin-containing chemotherapy; in addition, Keytruda can also be used second-line in patients whose disease progresses during or following platinum-based chemotherapy. Keytruda is given at a fixed intravenous dose of 200 mg every 3 weeks until disease progression or unacceptable toxicity, or up to 24 months if no disease progression. As with other checkpoint inhibitors, immune-mediated adverse reactions including pneumonitis, colitis, hepatitis, endocrinopathies, and nephritis can occur.

Kalydeco Wins Approval to Treat Additional Cystic Fibrosis Mutations

Because patient populations in CF are often small, clinical trials are often not feasible Read More...

Cystic fibrosis (CF) is an inherited genetic disease that affects sodium channels in the body and leads to build up of sticky mucous causing respiratory and digestive problems. This past week, the FDA approved Vertex's Kalydeco (ivacaftor) to treat 3 times the number of rare gene mutations, expanding the indication to 33 mutations. Kalydeco is a cystic fibrosis transmembrane conductance regulator (CFTR) potentiator indicated for patients age 2 years and older who have certain genetic mutations in the CFTR gene. With Kalydeco, results from an in vitro cell-based model system were been shown to reasonably predict clinical response to the added gene mutations, which led to the Kalydeco approval.

New FDA Commissioner Outlines Steps to Fight Opioid Addiction

The new budget sent to the U.S. Congress supports $27.8 billion in drug control efforts Read More...

Dr. Scott Gottlieb, the new FDA Commissioner, has announced the formation of an opioid policy steering committee to review the addiction and overdose crisis in the US. Misuse of potent painkillers such as OxyContin (oxycodone) and Vicodin (acetaminophen/hydrocodone) sends 1,000 Americans to emergency rooms each day. Gottlieb is suggesting a fix that may include mandated prescriber education and shorter courses of prescription opioids when appropriate. Research has shown that even after one day of opioid use, the risk of continued used at one year rises to 6 percent. The commissioner is seeking public input and professional advice on next steps to address this crisis.