US FDA grants Breakthrough Therapy Designation for food allergy drug Xolair

By Maggie Lynch contact

- Last updated on GMT

(Image:Getty/jacoblund)
(Image:Getty/jacoblund)

Related tags: food allergy, API, Fda

Genentech’s Xolair was granted a Breakthrough Therapy Designation by the US FDA.

Xolair (omalizumab), a therapy for the prevention of severe food allergy reactions after accidental exposure, was granted a Breakthrough Therapy Designation​ by the US Food and Drug Administration (FDA). The drug is part of Genentech’s portfolio, which now has 23 medicines with Breakthrough Therapy Designation.

Currently, there are no preventative treatments for severe food allergies. However, Xolair proved promising from the data of seven clinical studies accessing efficacy and safety with the use of it as a monotherapy or in combination with oral immunotherapy. The studies were supported by Genentech among other sponsors including the National Institute of Allergy and Infectious Diseases (NIAID).

The study concluded, according to Mark Eisner, VP of product development, immunology, infectious diseases, and ophthalmology at Genentech, “[Xolair] Omalizumab-treated patients tolerated approximately 0.5g and up to multiple grams of the offending food or [presented] minimal or no symptoms after 8-10 weeks of therapy.”

Xolair is a subcutaneous injectable prescription medicine that must be given by a health care provider in a healthcare setting.

Genentech and Novartis Pharmaceuticals Corporation have been working together with the NIAID to develop a pivotal study to further evaluate the efficacy and safety of Xolair in multiple food allergies.

Food allergies are increasingly prevalent in the US with roughly 8% of children and 4% of adults having food allergies​ leading to 30,000 food allergy-related emergency room visits each year and 150 deaths.

Food allergy treatment is an area of increasing interest to the pharma industry; we reported that in 2013 Sanofi provided an API for a food allergy therapy​, and Aimmune Therapeutics​ opened a manufacturing facility to develop a peanut allergy treatment in 2017.

Related topics: Markets & Regulations, Pipelines

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