Monthly News Roundup - May 2014

Durata’s Once-a-Week Antibiotic Dalvance Approved for Skin Infections

The U.S. Food and Drug Administration has approved injectable Dalvance (dalbavancin), an antibiotic used to treat adults with acute bacterial skin and skin structure infections caused by certain susceptible bacteria like Staphylococcus aureus (including methicillin-resistant strains) and Streptococcus pyogenes. Dalvance is the first drug FDA-designated as a Qualified Infectious Disease Product (QIDP), intended to encourage development of novel antibacterial agents. In clinical trials, subjects received Dalvance or vancomycin, another antibacterial drug; Dalvance was as effective as vancomycin for the treatment of the skin infections. Common side effects with Dalvance include nausea, headache and diarrhea.

Takeda’s Entyvio Approved to Treat Ulcerative Colitis and Crohn’s Disease

The U.S Food and Drug Administration (FDA) has approved Entyvio (vedolizumab) injection to treat adult patients with moderate to severe ulcerative colitis or Crohn‘s disease. Entyvio is not to be used as first-line therapy, but is indicated when one or more standard therapies, such as corticosteroids, immunomodulators, or TNF blockers have not been adequate. Entyvio is an integrin receptor antagonist that blocks circulating inflammatory cells to decrease inflammation in the gastrointestinal tract. The most common side effects in patients treated with Entyvio include headache, joint pain, nausea, and fever.

Merck’s Zontivity Approved to Lower Heart Attack and Stroke Risk

Antiplatelet drugs decrease the ability of platelets to adhere to each other to form a blood clot, lessening the risk of heart attack or stroke. The U.S. Food and Drug Administration (FDA) has approved a new antiplatelet agent, Zontivity (vorapaxar), in tablet form. In a study of roughly 25,000 participants, Zontivity, added to other anti-platelet agents such as aspirin and clopidogrel (Plavix) reduced the rate of heart attack, stroke, cardiovascular death, and urgent procedures to improve blood flow to the heart. Patients using Zontivity may bruise or bleed more easily and should report any unexpected bleeding to their health care provider.

FDA Approves Epanova to Treat Severely High Triglyceride Levels

The U.S. Food and Drug Administration (FDA) has approved AstraZeneca’s Epanova (omega-3-carboxylic acids), a fish oil mixture used in addition to diet for the treatment of adult patients with severe hypertriglyceridemia. Epanova is a free fatty acid and consists of a mixture of docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA). The dose of Epanova can be as little as 2 capsules per day, the first omega-3 medication with such a low pill burden. The company's statin product Crestor (rosuvastatin) is widely used to treat high cholesterol levels and may be developed further in a fixed dose combination with Epanova.

GSK’s Incruse Ellipta for COPD to Launch in Q4 2014

Roughly 27 million people in the US alone are affected by chronic obstructive pulmonary disease (COPD), an obstructive airway lung disease that interferes with normal breathing. Incruse Ellipta (umeclidinium) is a newly approved anticholinergic bronchodilator used in the treatment of COPD. Umeclidinium is a type of bronchodilator also known as a long-acting muscarinic antagonist (LAMA), and is contained in the Ellipta inhaler. The FDA-approved strength is 62.5 mcg given once a day. Other anticholinergic inhalers used in the treatment of COPD include ipratropium (Atrovent HFA), tiotropium (Spiriva Handihaler), and aclidinium (Tudorza Pressair).

Posted: May 2014


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