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There have been several noteworthy developments in the drug space recently, which will likely have a material impact on the companies in this sector and the markets they serve. In this review, we focus on the latest drugs approvals and other pipeline-related news. Companies mentioned include Novartis AG (NVS), Pfizer Inc. (PFE Free Pfizer Stock Report), and GlaxoSmithKline (GSK).  

Novartis Gets EU Approval For First Meningitis B Vaccine

On November 16th, the Swiss-based drugmaker announced it had won European approval for Bexsero, a vaccine used for the prevention of Meningitis B. This represents a significant opportunity for Novartis, as there is currently no approved vaccine offering broad protection against this particular type of meningitis on the market today. The company is hopeful that Bexsero will be a nice complement to another meningitis vaccine it already has on the market called Menveo, which covers other strains of the illness. Preliminary estimates suggest Novartis will be able to launch Bexsero in 2013, but success of the product will depend largely on its acceptance into the routine vaccination programs, which is usually regulated by each country’s respective government.

Pfizer Posts Favorable Results in Late-Stage Study

On November 19th, Pfizer announced that a once-daily version of its drug Lyrica in patients with fibromyalgia met its primary goal in a late-stage study. Fibromyalgia is a common pain condition affecting more than five million people in the United States. In the trial, patients who took the once-daily Lyrica, also known as pregabalin, went a significantly longer period of time before feeling pain versus those who took a placebo. This study is the second of three Phase 3 studies of the drug, which are expected to ascertain its potential use as a once-a-day therapy. Results of the first study in adults with certain types of seizures did not meet the primary endpoint, while the final study in patients with neuralgia is ongoing. Lyrica already has been approved for five indications in the United States, four of which are in the therapeutic area of pain.

GlaxoSmithKline Wins Approval For New Promacta Indication

On November 19th, GSK announced that the FDA approved Promacta for the treatment of low blood platelet counts in patients with chronic Hepatitis C. This represents the first supportive care treatment available to patients who are ineligible for interferon-based therapy due to their low blood platelet counts. Based on the study, when Promacta was used in combination with these commonly prescribed interferon-based therapies, it significantly improved the patient’s chances of achieving a viral cure. At present, it is estimated that fewer than 200,000 people, out of the 4.2 million suffering from chronic Hepatitis C in the U.S., have low enough platelet counts where Promacta could be useful.

At the time of this article’s writing, the author did not have positions in any of the companies mentioned.