Novartis aims to bring first oral asthma drug to market in two decades

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Xolair, co-promoted by Genentech and Novartis, was the first biologic to snag approval for moderate to severe persistent allergic asthma in patients aged 12 and older.

An investigative agent in the Novartis asthma pipeline could give biologics — including the company's own Xolair, a co-promotion with Genentech — a run for their money. Developed to similarly block the action of inflammatory cells called eosinophils, fevipiprant could be the first new oral medication for the treatment of asthma in nearly 20 years.

Small molecules dominate the asthma therapeutic market, with the exception of three monoclonal antibodies developed to treat severe forms of asthma that are uncontrolled.

Excitement over the drug's potential peaked last summer when Phase II trial results were released in England. Though it included a mere 61 subjects, the trial showed improved lung function, reduced lung inflammation, and repaired airway linings over the course of 12 weeks.

See also: Drugmakers target severe asthma patients with biologics, but payers raise pricing issue

As many as one in four people with severe asthma do not achieve control with current therapies. If approved, Novartis' oral DP2 receptor antagonist may help reduce the levels of uncontrolled disease and unmet needs that currently exist.

“What's interesting about this agent is that its use is expected to overlap with the target population for the new biologics. But because it's administered orally, it likely would be cheaper,” says Lisa Kennedy, Ph.D., senior principal, inThought Research.

Although the new drug remains under investigation, Novartis representatives expect the daily oral preparation to be simple and easy to take alongside current standard-of-care therapies. Fevipiprant's efficacy and safety is being evaluated in two Phase III trials (Luster) in patients with severe asthma stratified by blood eosinophils. Eric Althoff, head of global media relations at Novartis, says filing could occur as early as 2019.

The drug's oral administration could be a welcome change for many patients. “Being the first new oral asthma medication in two decades in a market domi­nated by drugs administered either by inhalation, injection, or infusion raises excitement in the medical community,” notes Joern Kleebach, global account director, GfK Health.

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Fevipiprant is the first asthma treatment to use a dual pathway approach by inhibiting eosinophils while stopping inflammation in the airway lining and repairing any damage. “A type of white blood cell, eosinophils are a potent marker of inflammation,” Althoff explains.

Kennedy says fevipiprant is likely to be used as a “pre-biologic” add-on maintenance treatment in severe asthma patients with an eosinophilic phenotype not adequately controlled by standard-of-care therapy.

Kleebach adds fevipiprant could significantly reduce preventable asthma attacks and related hospitalizations, and improve symptoms. “The combination of these factors could make it a game changer,” he notes.

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