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Weekly Drug News Round Up - October 23, 2013

UCB’s Cimzia Gains New Indication For Ankylosing Spondylitis

Common side effects with Cimzia may include respiratory infections, rash, urinary tract infections and headache Read More...

Cimzia (certolizumab pegol) has been approved by the U.S. Food and Drug Administration for ankylosing spondylitis (AS), a form of arthritis that primarily affects the spine and leads to inflammation, pain and, in the most severe cases, immobility. In clinical trials, a greater proportion of AS patients treated with Cimzia 200 mg every two weeks or 400 mg every four weeks achieved significant results compared to placebo. Responses were similar in patients receiving Cimzia 200 mg every two weeks or 400 mg every four weeks. Cimzia is also approved to treat psoriatic arthritis, rheumatoid arthritis and Crohn's disease.

Genentech’s Actemra Approved in a Subcutaneous Dosage Form

Actemra is now approved for both subcutaneous and intravenous administration in rheumatoid arthritis Read More...

Actemra (tocilizumab) has been approved by the U.S. Food and Drug Administration in a subcutaneous (SC) formulation to treat adult patients with moderate to severe rheumatoid arthritis who have had inadequate treatment with one or more disease-modifying antirheumatic drugs, such as methotrexate (MTX). SC injections are given under the skin, are more convenient, and may be associated with less infection risk than intravenous (IV) formulations. Like the IV form, the SC dose form can be used both as a single-agent therapy and in combination with MTX or other non-biologic DMARDs. The Actemra pre-filled syringe (PFS) injection formulation will be available in November.

Actelion’s Opsumit Now Approved for Pulmonary Arterial Hypertension

Opsumit is in a restricted access program due to a risk for birth defects in this class Read More…

The U.S. Food and Drug Administration has approved Opsumit (macitentan) for the treatment of pulmonary arterial hypertension (PAH), a chronic and serious lung disease that can lead to a required lung transplantation or death. Opsumit is classified as a dual endothelin receptor antagonist, and is in a similar drug class as Tracleer (bosentan) and Letairis (ambrisentan). Clinical trials spanned two years with over 740 patients receiving active drug or placebo. Opsumit was found to be effective in delaying disease progression including a decline in the ability to exercise, worsened PAH symptoms or added medication.

Novoeight Approved for Hemophilia But Launch Delayed

Awaiting patent expirations, Novo Nordisk will not have a U.S. launch of Novoeight until April 2015 Read More...

The U.S. Food and Drug Administration has approved Novoeight (turoctocog alfa), a recombinant coagulation factor VIII indicated for use in children and adults with hemophilia A. Hemophilia is an inherited bleeding disorder that primarily affects males. Roughly one in 5,000 males born in the United States has hemophilia. People with hemophilia A need to replace factor VIII protein, which is essential for proper blood clotting. Novoeight will be used to help to control and prevent bleeding episodes and for management of bleeding in relation to surgical procedures. Other similar agents on the market for hemophilia include Recombinate, Kogenate FS, and Advate.

Zorvolex: New Approval Contains Lower Strength Diclofenac

Serious side effects with NSAIDs may include stomach ulcers bleeding, kidney damage, and heart attack or stroke Read More...

The U.S. Food and Drug Administration has approved Zorvolex (diclofenac) capsules, a nonsteroidal anti-inflammatory drug (NSAID) for the treatment of mild to moderate pain. The dosage of Zorvolex is 18 or 35 milligrams orally three times a day; it was approved at dosage strengths that are 20 percent lower than currently available diclofenac products. Zorvolex contains diclofenac as submicron particles with greater surface area allowing faster dissolution, which may help reduce side effects. Original diclofenac, approved in 1988 as the prescription brand Voltaren, is now available generically in delayed and extended-release formulations.