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Shutdown Delays FDA Peanut Allergy Drug Review

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15 Jan. 2019. Regulatory review of a drug to prevent allergic reactions to peanuts appears to be delayed by the shutdown of some U.S. government operations. The industry newsletter Biopharma Dive reports today that the Food and Drug Administration has funds for only some of its functions, and review of drugs like Aimmune Therapeutics’ preventive treatment for peanut allergies is not one of them.

As the political impasse that blocks funding for about a quarter of the U.S. government extends into its 25th day, FDA is continuing some of its public health functions, particularly in high-risk issues and emergencies. The agency is also relying on funds still in its coffers from user fees paid by companies for review of their products. These funds do not require appropriations from Congress, and FDA is continuing reviews of products for which user fees are already paid.

Aimmune Therapeutics, in Brisbane, California, develops a form of immunotherapy for food allergies, starting with peanuts. The company’s technology known as Codit exposes people with food allergies to increasing amounts of the allergens over 6 months, thereby desensitizing the individuals to the allergen. Codit, says Aimmune, enhances conventional oral immunotherapies by precisely controlling the amount of offending food protein ingested by people with food allergies and establishing treatment routines that start with very small amounts and gradually increasing the amounts over time.

As reported by Science & Enterprise in November 2018, a late-stage clinical trial of Aimmune’s peanut allergy preventive treatment code-named AR101 shows the treatment desensitizes children and adolescents with peanut allergies against reaction-causing proteins in peanuts for one year. Based on these and other clinical trial results, the company submitted its application to FDA for regulatory approval on 21 December 2018, the day before the shutdown began.

Unfortunately for Aimmune, user fees do not apply to blood and allergy-related products, according to a series of tweets today from FDA commissioner Scott Gottlieb, and reported by Biopharma Dive. “More specifically, for products not covered by a user fee program, like most blood and allergenic extract products,” tweets Gottlieb, “FDA does not have carryover user fee funding to continue reviewing pending or accepting new applications.”

Biopharma Dive quotes sources at Aimmune that say the company paid user fees as part of its application for AR101. The company did not answer further requests for comment from Biopharma Dive.

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