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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finance.yahoo.com
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Palforzia's peanut allergy treatment use in Europe

Roche and Novartis’ Xolair (omalizumab) received FDA approval in February 2024 as the first drug to reduce allergic reactions from accidental food exposure, including peanuts, milk, and wheat. Additionally, Palforzia's peanut allergy treatment expanded in Europe to include toddlers.
biospace.com
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Layoff Tracker: Cassava Axes Third of Staff in Aftermath of Failed Phase III Alzheimer's Drug Trial

2024 was a challenging year for the biopharma industry, with companies like Bayer, Bristol Myers Squibb, and Johnson & Johnson cutting hundreds to thousands of jobs. Cassava Sciences announced layoffs of 10 employees, 33% of its workforce, following a failed Phase III trial for its Alzheimer's drug. CytomX Therapeutics cut 40% of its staff to focus on clinical programs. Velia, a San Diego biotech, is shutting down, affecting 47 employees. Regeneron's acquisition of Oxular led to layoffs, with no Oxular employees joining Regeneron. Javara, Ring Therapeutics, Outlook Therapeutics, Editas, Bavarian Nordic, BenevolentAI, Chroma Medicine and Nvelop Therapeutics, Cellectar Biosciences, Carisma Therapeutics, Belharra Therapeutics, National Resilience, AmplifyBio, Agenus, Alligator Bioscience, Idorsia Pharmaceuticals, Kronos Bio, Novartis, Recursion Therapeutics, Medigene, Alector, Bristol Myers Squibb, Sonata Therapeutics, 23andMe, Johnson & Johnson, Merck, Gilead Sciences, Adaptimmune, Sensei Biotherapeutics, Marinus Pharmaceuticals, Orna Therapeutics, Thermo Fisher Scientific, Charles River Laboratories, Aurinia Pharmaceuticals, Viracta Therapeutics, Astellas Gene Therapies, Sana Biotechnology, Sage Therapeutics, Compass Pathways, Spero Therapeutics, ICON, Pfizer, Takeda, SalioGen Therapeutics, Evonik, Medtronic, CareFusion Resources, Turnstone Biologics, Leo Pharma, Astellas Pharma, Prime Medicine, Kaléo, Stryker, Relay Therapeutics, ImmunityBio, Shattuck Labs, Inventprise, bluebird bio, Athira Pharma, AGC Biologics, Oncternal Therapeutics, Biosense Webster, Vesigen Therapeutics, Connect Biopharma, BioMarin, IN8bio, Edwards Lifesciences, DermTech, Repare Therapeutics, Genentech, Tome Biosciences, Aadi Bioscience, Lykos Therapeutics, Evotec, Galera Therapeutics, Grail, Ovid Therapeutics, Lexicon Pharmaceuticals, Acelyrin, Boundless Bio, FibroGen, Ajinomoto Bio-Pharma Services, AN2 Therapeutics, Entero Therapeutics, Precigen, Sumitomo Pharma America, uniQure, Vir Biotechnology, Arbutus Biopharma, HilleVax, and Bayer also announced significant layoffs, reflecting a tough year for the industry.

Most influential drug approvals of 2024

In 2024, 19 notable drugs were approved in the U.S., including Dupixent for COPD, Cobenfy for schizophrenia, FluMist nasal vaccine, Neffy for allergies, Yorvipath for hypoparathyroidism, Zunveyl for Alzheimer's, Voquezna for GERD, Kisunla for Alzheimer's, Ohtuvayre for COPD, Wakix for pediatric narcolepsy, Capvaxive vaccine, mRESVIA mRNA vaccine, Winrevair for pulmonary hypertension, Nexletol for cholesterol, Tryvio for high blood pressure, Wegovy for cardiovascular risk, Xolair for food allergies, Amtagvi for melanoma, and Dupixent for eosinophilic esophagitis in children.
foxnews.com
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These FDA-approved medications and vaccines were 'most influential' in 2024

2024 saw FDA approvals for innovative drugs like Tryvio for high blood pressure, Neffy for severe allergies, and Dupixent for COPD. GoodRx highlighted 19 influential drug and vaccine approvals, emphasizing their potential significant impact on human health.
bioworld.com
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Other news to note for December 31, 2024

Bio-Thera Solutions and Tabuk Pharmaceutical collaborate on BAT-2206. Corxel acquires CX-11 globally. Exicure and GPCR Therapeutics sign MOU for GPCR USA acquisition. Neuphoria becomes Bionomics' parent. Rapt and Jemincare agree on HYB-1904 development. Wuxi Apptec sells ATU operations to Altaris.
hcplive.com
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Allergy Year in Review: 2024

2024 marked significant advancements in allergy medicine, including FDA approvals for treatments like omalizumab (Xolair) for food allergies, fluticasone propionate nasal spray (XHANCE) for chronic rhinosinusitis, and epinephrine nasal spray (neffy) for anaphylaxis. New data on allergens in infant skincare and guidelines for allergen immunotherapy documentation were also highlighted.
healio.com
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Top 10 food allergy stories of 2024

2024's top food allergy stories include FDA's omalizumab approval for IgE-mediated food allergy, Uber Eats' controversial Super Bowl ad, and discussions on food allergy treatment, bullying, and media impact.
bcbsil.com
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Pharmacy Program Updates: Prior Authorization Changes Effective March 1, 2025

The pharmacy prior authorization program ensures safe, cost-effective medication use. Changes effective March and April 2025 include new criteria and programs for various drugs, impacting members with Prime Therapeutics-administered benefits. Decisions remain between patients and providers, with coverage subject to benefit plan terms.
globenewswire.com
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RAPT Therapeutics and Shanghai Jemincare Pharmaceutical

RAPT Therapeutics and Jemincare entered an exclusive license agreement for JYB1904 (RPT904), a half-life extended anti-IgE monoclonal antibody. RAPT gains worldwide rights excluding China, paying Jemincare $35M upfront, up to $672.5M in milestones, and royalties. Jemincare conducts Phase 2 trials in asthma and chronic spontaneous urticaria in China, while RAPT plans a Phase 2b trial in food allergy in 2025.
thebionews.net
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Celltrion secures domestic approval for 'Avtozma' as a first mover, aiming to achieve 11

Celltrion received approval for Avtozma, a biosimilar of Actemra, for autoimmune diseases, becoming the first in Korea. Avtozma is approved for the same indications as Actemra, including rheumatoid arthritis. Celltrion also aims for approval in Europe and the U.S., advancing its 11-product portfolio goal by 2025.
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