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FDA approves Merck's asthma combo Dulera

World News | June 24, 2010


Kevin Grogan

Regulators in the USA have given the green light to Merck & Co’s combination athma treatment Dulera.

The US Food and Drug Administration has approved Dulera, which combines an inhaled corticosteroid [Nasonex/Asmanex (mometasone)] with a long-acting beta2-agonist [Foradil (formoterol)] for use by asthmatics aged 12 and over, though Merck noted it has not been given the thumbs-up for the relief of acute bronchospasm. The approval is principally based on two Phase III trials involving 1,509 patients with persistent asthma uncontrolled by medium or high-dose corticosteroids.

Results from both studies showed patients receiving Dulera, which Merck got hold of through its acquisition of Schering-Plough, experienced significant improvement from baseline in lung function at week 12 compared to mometasone furoate. In the first trial, these differences were maintained through week 26.

The company quoted Michael Blaiss of the University of Tennessee Health Science Center in Memphis as saying that “asthma control is an important treatment goal and Dulera provides a new option for physicians to help manage this chronic condition in appropriate patients”. It will now go up against two similar combos - GlaxoSmithKline’s GlaxoSmithKline’s Advair/Seretide (salmeterol/fluticasone) and AstraZeneca's Symbicort (budesonide/formoterol) – and is expected to be available by the end of July.

The Dulera approval comes at a time when the FDA has issued warnings that LABAs, such as formoterol, should never be used alone in the treatment of the disease.

Chagas disease drug goes into Phase II
Merck also noted that it will begin a Phase II study of its oral antifungal agent posaconazole, a candidate for chronic Chagas disease. The latter results from infection with the parasite Trypanosoma cruzi that is spread by biting insects and affects nearly eight million people in Latin America.

Merck noted that of those, 30%-40% will develop serious cardiac disease, digestive disease, or both. Currently, only two drugs are approved – benznidazole and nifurtimox – and Roger Pomerantz, head of infectious diseases at Merck Research Laboratories, said that "while significant progress has been made in recent years, “no new drugs have been approved for the treatment of chronic Chagas disease in over three decades”.

Posaconazole, another drug from the S-P stable, is marketed in the USA, Europe and several other countries as Noxafil for prophylaxis of invasive Aspergillus and Candida infections.

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