MedPath

Omalizumab

Generic Name
Omalizumab
Brand Names
Xolair, Omlyclo
Drug Type
Biotech
Chemical Formula
-
CAS Number
242138-07-4
Unique Ingredient Identifier
2P471X1Z11
Background

Omalizumab, manufactured by Genentech, was first FDA approved in 2003 to treat adults and children 12 years of age and older with moderate to severe persistent allergic asthma which is not controlled by inhaled steroids . Since its U.S. approval, more than 200,000 patients older than 12 with allergic asthma have been treated . In September 2018, a new prefilled syringe formulation of this drug was approved by the FDA .

Indication

This drug is an anti-IgE antibody indicated for:

Associated Conditions
Chronic Idiopathic Urticaria, Moderate Asthma, Severe Asthma
Associated Therapies
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menafn.com
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RAPT Therapeutics And Shanghai Jemincare Pharmaceutical Announce Exclusive License Agreement For Novel Long-Acting Anti-Ige Antibody

RAPT Therapeutics and Jemincare enter an exclusive license agreement for RPT904, a novel anti-IgE monoclonal antibody, with RAPT gaining worldwide rights excluding China. Jemincare receives $35M upfront, up to $672.5M in milestones, and royalties. RAPT plans a Phase 2b trial in food allergy; Jemincare conducts Phase 2 trials in asthma and CSU in China.
manilatimes.net
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RAPT Therapeutics and Shanghai Jemincare Pharmaceutical Announce Exclusive License Agreement for Novel Long-Acting anti-IgE Antibody

RAPT Therapeutics and Jemincare announced an exclusive license agreement for RPT904, a novel anti-IgE monoclonal antibody, with RAPT gaining worldwide rights excluding China. Jemincare receives $35M upfront, up to $672.5M in milestones, and royalties. RAPT plans a Phase 2b trial in food allergy, while Jemincare conducts Phase 2 trials in asthma and CSU in China.
healthline.com
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Have a Peanut Allergy? Here Are the Treatment Options

Peanut allergy treatments are advancing, with options like oral immunotherapy, biologics, and epicutaneous immunotherapy offering hope for better management. These methods aim to reduce severe reactions by gradually increasing tolerance to peanuts. While no cure exists, these treatments can significantly improve quality of life for those affected.

Health Canada Approves First Omalizumab Biosimilar

Health Canada approved Celltrion's Omlyclo, the first omalizumab biosimilar in Canada, for treating chronic idiopathic urticaria, allergic asthma, and chronic rhinosinusitis with nasal polyps. Omlyclo demonstrated bioequivalence to Xolair in a phase 3 study, and is under FDA review. Celltrion also received positive CHMP opinions for three other biosimilars in Europe.
kedglobal.com
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Celltrion gets approval of Omlyclo in Canada

Celltrion Inc. receives Health Canada approval for Omlyclo, a biosimilar of Xolair, enabling sales in Canada for allergic asthma, chronic rhinosinusitis with nasal polyps, and chronic idiopathic urticaria.
allergicliving.com
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DBV Upbeat on Allergy Patch Studies, Approval Chances

DBV Technologies progresses with Viaskin patch for peanut and milk allergies, aiming for FDA approval. Studies show promising results, with 81% of toddlers tolerating peanuts after 2 years. The patch, part of epicutaneous immunotherapy, may offer sustained unresponsiveness. DBV plans to expand treatment to cashew and potentially other allergens.
globenewswire.com
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Microbial Fermentation Technology Market to Reach USD 53.25

The microbial fermentation technology market was valued at USD 31.97 Billion in 2023 and is projected to reach USD 53.25 Billion by 2032, growing at a CAGR of 5.91%. This growth is driven by advancements in biotechnology, demand for sustainable production, and investments in alternative protein companies. Key segments include antibiotics, monoclonal antibodies, and CMOs & CDMOs, with Asia Pacific leading the market and North America poised for fast growth.
kplctv.com
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New drug treating food allergies gets FDA approval

Anabelle Terry, with a lifelong nut allergy, now eats nuts due to a study using Omalizumab (Xolair), which binds to allergy cells, reducing reactions. The study showed kids previously reacting to less than a third of a peanut could tolerate more than two whole peanuts. The drug gained FDA approval in February for treating severe allergies, usable from age one.
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