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FDA Approves Nucala As Treatment For Severe Asthma

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The U.S. Food and Drug Administration releases a go signal for Nucala by GlaxoSmithKline to be used in conjunction with other asthma medications to treat severe asthma.

Nucala, also known as mepolizumab, is now allowed to be used by patients 12 years and older who have a history of severe asthma attacks even when on other asthma maintenance medications.

Bronchial Asthma is a lifelong condition characterized by wheezing, breathlessness and chest pains. It is mainly caused by spasms in the bronchi of the lungs that can block a person's airway.

Approximately one in 12 people or a total of 25 million in the United States are suffering from asthma. More than half of these people (53 percent) suffered asthma attacks in 2008.

The approval came after clinical trials showed promise in reducing asthma attacks that required hospitalization and breaks in between these attacks.

"This approval offers patients with severe asthma an additional therapy when current treatments cannot maintain adequate control of their asthma," Dr. Badrul Chowdhury, director of the Division of Pulmonary, Allergy, and Rheumatology Products in the FDA's Center for Drug Evaluation and Research said in a press release.

The drug is administered once every month by subcutaneous injection in areas like upper arm, thigh or abdomen. It is a monoclonal antibody that inhibits interleukin-5 for adults and teenagers who has severe asthma with an eosinophilic phenotype.

People with an eosinophilic phenotype of asthma are the ones who react to allergens in the environment. Eosinophils play a pivotal role in immune development and asthma as overproduction may lead to inflammation in the lungs.

Common side effects of Nucala include reaction on injection sites, back pain, weakness and headache. Meanwhile, patients are advised to continue their current medications for asthma, including high-dose inhaled corticosteroids and at least one asthma control medicine.

"Following today's approval, GSK can now offer, as part of our overall respiratory portfolio, a first-in-class biologic treatment for severe asthma patients whose condition is driven by eosinophilic inflammation," Eric Dube, senior vice President and head of GSK Global Respiratory Franchise, said in a press release.

"Our research has allowed us to better understand the specific role eosinophils play in severe asthma. We are proud of our contribution to this emerging area of science that has led to the approval of the first anti-IL5 treatment. We aim to offer this medicine to patients as soon as possible," Dube added.

Photo: Yale Rosen | Flickr

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