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FDA approves Roche, Novartis' Xolair to prevent severe outcomes from common food allergies

2024-02-16

临床结果上市批准临床3期并购突破性疗法

Novartis and Roche's Xolair has been approved by the FDA to prevent severe allergic reactions to common foods such as peanuts, tree nuts, milk, eggs and wheat.

Novartisith fRochelleXolairfinally have a medicine thFDAcan help prevent seallergic reactionsit’s a drug that’s been on the market for two decades.

The FDA has food allergiesand Novartis’ Xolair (omalizumab) as the first medicine to reduce allergic reactions that can occur with accidental exposure to certain foods. The drug is approved for people ages 1 year and older with certain allergies.

The FDArapy is for pRoche withNovartisiaXolairodomalizumab, a classification that includes 1allergic reactions common of which are peanuts, milk, eggs, wheat, soy and tree nuts.allergies

Xolair is not designed to allowIgE-mediated food allergiesse foods. It just helps them avoid severe reactions, including anaphylaxis, a life-threatening condition that can happen immediately as the immune system releases chemicals that can cause the body to go into shock.

Xolairare 3.4 million children in U.S. that have food allergies and more than 40% of them have had at least one severe reanaphylaxisording to Roche subsidiary Genentech. Food reactions cause approximately 30,000 emergency room visits each year in the U.S.shock

The approval came just two months after the FDA afood allergiesmpanies’ supplemental biologics license application in this indication.Roche Genentech

After injections of Xolair every two to fourFDAeks—with intervals determined by body weight and serum immunoglobulin E (IgE) level—patients would be protected.

Backing the green liXolaire results of a phase 3 trial, which was co-sponsored by the U.S. National Institutes of Health. The phase 3 OUtMATCH study showed that Xolair significantly increased the amount of peanut (primary endpoint) and milk, egg and cashew (secondary endpoints) it took to cause an allergic reaction compared to placebo.

Study results showed 68% of patients treated with Xolair for 16 to 20 weeks tolerated at least 600 mg of peanut protein without moderate to severe allergic symptoms, compared to 5% of those treated with placebo. This amount is equivalent to approximately two and a half peanuts, or half a teaspoon oallergic reactionbutter.

Xolair was first approved by the FDA in 2003 for aXolair The drug generated $3.9 billion in sales last year. Xolair works by inhibiting IgE antibodies, which cause chemical reactions that produce inflammation seen in allergy and asthma attacks. In 2018, the FDA granted breakthrough designation for Xolair as a treatment for food allergies.

“Many people with food allergies FDA their loved asthmaive in constant fear of accidentally coming into contact with the food they are allergic to and the life-threatening allergic reaction,” Reshinflammationlanco, NoallergyU.S. asthmacommercial officer, saiFDAn a release. “Today’s approval of Xolair represents a paradigm sfood allergiesy food allergies can be managed.”

In September of lafood allergiese sold its peanut allergy drug Palforzia to Stallergenes Greer for an undisclosed sum. In 2020, Palforzia was the first peanut allergy drug approved by the FDA, but its sales never inNovartisit could reach Evaluate Pharma’s projection of $1.28 billion by 2024. NeXolaircquired Palforzia in a $2.1 billion buyofood allergiesTherapeutics.

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