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Weekly Drug News Round Up - August 27, 2014

ViiV Healthcare’s Triumeq FDA-Approved for HIV

Triumeq comes with a boxed warning about the risk of allergic reactions, lactic acidosis, severe hepatomegaly, and exacerbations of hepatitis B Read More...

The U.S. Food and Drug Administration (FDA) has approved Triumeq (abacavir/dolutegravir/lamivudine) tablets for the treatment of HIV-1 infection. Triumeq is a fixed-dose combination that combines the integrase strand transfer inhibitor dolutegravir, with the nucleoside reverse transcriptase inhibitors (NRTIs) abacavir and lamivudine. Approval was based on two studies: the non-inferiority Phase III study (SINGLE) compared to Atripla, and a bioequivalence study. At 96 weeks, 80% of participants on the dolutegravir-based regimen were virologically suppressed compared to 72% of participants on Atripla. One-year superiority over Atripla was demonstrated based on better tolerability and fewer drop-outs due to side effects.

GSK’s Arnuity Ellipta Get Ok for Asthma in Patients 12 Years and Older

Arnuity Ellipta should not be used if you have a severe milk allergy Read More...

The U.S. Food and Drug Administration (FDA) has approved Arnuity Ellipta (fluticasone furoate inhalation powder), a once-daily inhaled corticosteroid for maintenance treatment of asthma in patients 12 years and older. It is not indicated for relief of acute symptoms of asthma, which should be treated with a rescue inhaler (bronchodilator) like albuterol. Arnuity Ellipta is available as a dry powder inhaler. In GlaxoSmithKline clinical trials, the efficacy and safety of Arnuity Ellipta was evaluated in more than 3,600 patients with asthma. The approved doses are 100 micrograms (mcg) or  200 mcg.

Eliquis Gets New Indication for Treatment of Blood Clots

Every year roughly 900,000 Americans are affected by DVT and PE Read More...

The U.S. Food and Drug Administration has approved Eliquis (apixaban) for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and to reduce the risk of recurrent DVT and PE. Eliquis, an oral Factor Xa inhibitor anticoagulant, is also approved to lower stroke risk due to a blood clot in patients with atrial fibrillation. In clinical trials, Eliquis 10 mg twice daily for one week followed by 5 mg twice daily for six months demonstrated efficacy comparable to standard of care (enoxaparin followed by warfarin) in treating DVT and PE patients for the primary endpoint of recurrent, symptomatic venous thromboembolism (VTE), or VTE-related death.

Promacta Approved for Difficult-to-Treat Severe Aplastic Anemia

Common side effects occurring in 20 percent or more of patients were nausea, fatigue, cough, diarrhea, and headache Read More...

The U.S. Food and Drug Administration (FDA) has approved once-daily Promacta (eltrombopag) in patients with severe aplastic anemia (SAA) who have had an insufficient response to immunosuppressive therapy (IST). SAA is a rare but serious blood disorder where the bone marrow fails to make enough red blood cells, white blood cells, and platelets. In a Phase II study, Promacta was administered at an initial dose of 50 milligrams (mg) once daily for two weeks and increased over two-week periods up to a maximum dose of 150 mg. Forty percent of patients experienced a response in at least one type of blood cell after week twelve.

Zorvolex Approved to Treat Chronic Osteoarthritis Pain

Zorvolex still carries the heart warnings that other NSAIDs carry even though it is a low dose diclofenac Read More...

Zorvolex (diclofenac), a nonsteroidal anti-inflammatory drug (NSAID), has received a second approval for the management of chronic osteoarthritis (OA) pain. Zorvolex, manufactured by Iroko Pharmaceuticals, was originally FDA-approved for the treatment of acute pain in adults in October 2013. Zorvolex is the first low dose NSAID using a proprietary technology to create diclofenac submicron particles that are 20 times smaller than their original size with faster dissolution. Data for approval came from 12-week trials in patients between 41 and 90 years with OA of the hip or knee. Zorvolex 35 milligrams three times daily is the approved dose for OA.