Patients must also take other medications, including high-dose inhaled corticosteroids and at least one additional asthma drug.
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The commercial launch will commence as soon as possible. Reuters notes that analysts on average expect Nucala to generate annual sales of $756 million (£491 million) by 2020, according to Thomson Reuters data.
The first proof of concept lead investigator and recent investigator for the Phase III Mepolizumab as Adjunctive Therapy in Patients with Severe Asthma (MENSA) study, goes on to say, “As a clinician, the prospect of a treatment that can specifically target the underlying cause of the disease for patients whose condition is driven by eosinophilic inflammation is exciting”. The inclusion of patients as young as 12 years old is a surprise since the FDA’s advisory committee voted 10-4 against the use of Nucala in adolescents.
Delivered as a 100-mg, fixed-dose, subcutaneous injection to the upper arm, thigh or abdomen once every four weeks, Nucala is created to work by reducing the levels of blood eosinophils, a type of white blood cell linked to the development of asthma.
“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. It is also not administered for the relief of acute bronchospasm or status asthmaticus.
In controlled trials, patients who received Nucala had fewer asthma attacks that required hospitalization or emergency-room visits and reported longer breaks between asthma attacks.
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Common adverse events associated with the new drug include headache, injection site reactions, back pain, and weakness. The company said patients should consider a varicella vaccination, if medically appropriate, before starting therapy with Nucala.
