Monthly News Roundup - August 2014
Belsomra: Merck’s First-in-Class Insomnia Treatment Approved
The U.S. Food and Drug Administration (FDA) approved the long-awaited Belsomra (suvorexant) tablets for difficulty in falling and staying asleep (insomnia). Belsomra, in a new class called orexin receptor antagonists, blocks the action of orexin, a chemical involved in the sleep-wake cycle in the brain. The FDA has approved Belsomra in various 5 to 20 milligram (mg) strengths. Belsomra is taken once 30 minutes before bed with a max daily dose of 20 mg. After taking, at least seven hours should remain for uninterrupted sleep. Belsomra is expected to be available in pharmacies by early 2015 as a CIV controlled substance.
ViiV Healthcare’s Triumeq FDA-Approved for HIV
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.
Janssen’s Invokamet Approved for Type 2 Diabetes
A new government report indicates that two out of every five Americans will develop type 2 diabetes in their lifetime. As an added tool in this growing epidemic, the U.S. Food and Drug Administration (FDA) has approved Invokamet, a combination of canagliflozin (Invokana) and metformin in a single tablet for type 2 diabetics who are not adequately controlled with either drug alone. Invokamet, given twice daily, is the first U.S.-approved combination of a sodium glucose co-transporter 2 (SGLT2) inhibitor with metformin. This month, the FDA also approved Jardiance (empagliflozin), a single entity SGLT2 inhibitor in the same class as Invokana.
GSK’s Arnuity Ellipta Gets Ok for Asthma in Patients 12 Years and Older
The U.S. Food and Drug Administration (FDA) has approved Arnuity Ellipta (fluticasone furoate inhalation powder), a once-a-day 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. 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. Arnuity Ellipta should not be used in patients with a severe milk allergy.
Boehringer Ingelheim’s Striverdi Respimat Okayed for COPD
The U.S. Food and Drug Administration (FDA) has approved Striverdi Respimat (olodaterol) inhalation spray for patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. Once-daily Striverdi Respimat is a long-acting beta-adrenergic agonist (LABA) that relaxes the lung airway muscles. In clinical trials of 3,104 people with COPD, Striverdi Respimat showed improved lung function compared to placebo. Common side effects included nasopharyngitis (runny nose), upper respiratory tract infection, bronchitis, and cough. All LABA’s carry a boxed warning of increased risk of asthma-related death; Striverdi Respimat is not approved as a single entity to treat asthma.
Posted: August 2014