FDA Analyzes Potential Limitations to GSK’s New Asthma Drug

FDA Analyzes Potential Limitations to GSK’s New Asthma Drug

GSKThe U.S. Food and Drug Administration (FDA) recently produced a preliminary report regarding GlaxoSmithKline Plc‘s investigational combined therapy for the treatment of chronic breathing problems that revealed no additional safety issues. The medication, called Breo Ellipta, is being tested as a potential treatment for asthma.

Breo Ellipta is an inhaled drug combination that includes both corticosteroid and vilanterol and works by softening the interior of the airways. The medication is already being commercialized in the US for the treatment of chronic obstructive pulmonary disease (COPD) and the FDA is expected to provide a final decision about its approval within the next few days.

According to an announcement from the FDA, there were no deaths among patients with asthma who were treated with Breo Ellipta in the studies conducted and reviewed by the administration. The safety profile of Breo Ellipta was comparable to other asthma treatments that combine steroids and long-acting beta-adrenoceptor agonists (LABA).

Vilanterol, a LABA compound, has been connected to deaths in patients with asthma in the past. The administration also reported it is still going to analyze the benefits of using the drug, given the lack of consistent data in trials. GlaxoSmithKline expects further announcements from the FDA, after having provided results from their studies that demonstrated the capacity of Breo Ellipta to retard the worsening of the symptoms of the disease.

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GlaxoSmithKline recently made available in the American markets two newly approved products for the treatment of both COPD and asthma, as the company has been focused on expanding its portfolio of therapies for the two lung diseases in the United States. In less than two years, the company has launched four inhaled therapies to address respiratory conditions, all delivered through the Ellipta inhaler.

The new products are Arnuity Ellipta (fluticasone furoate inhalation powder), a once-a-day inhaled corticosteroid (ICS) medicine, designed as maintenance treatment asthma patients, as well as Incruse Ellipta (umeclidinium bromide), an anticholinergic indicated for the long-term, once-daily maintenance treatment of airflow obstruction in patients with COPD.

Last November, the company forwarded regulatory submissions, both in US and Europe, for Mepolizumab as a maintenance treatment for severe eosinophilic asthma. The submission involved a Biologics License Application submitted to the FDA and a Marketing Authorization Application to the European Medicines Agency for the use of mepolizumab as a maintenance treatment in patients who are at least 12 years old that suffer from severe eosinophilic asthma (for the US) and have a history of exacerbations and/or dependency on systemic corticosteroids (for Europe).

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