Home Food Allergies FDA Approves LongBio’s Anti-IgE Antibody for Medical Trials to Deal with Meals...

FDA Approves LongBio’s Anti-IgE Antibody for Medical Trials to Deal with Meals Allergy

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SHANGHAI, Nov. 25, 2024 /PRNewswire/ — LongBio is proud to announce that the Nationwide Medical Merchandise Administration (NMPA, China) has permitted the Investigational New Drug (IND) utility for LP-003, the corporate’s next-generation anti-IgE antibody, to start a scientific trial for the remedy of meals allergy.

Meals allergy is a rising international well being concern, affecting an estimated 2-10% of the inhabitants, relying on age and area. Present remedy choices are restricted, emphasizing the pressing want for novel therapies that not solely enhance symptom management but in addition present a long-acting sustained reduction. The FDA’s current approval of omalizumab for meals allergy in February 2024 has strengthened the therapeutic potential of anti-IgE remedy as a dependable and promising resolution.

LP-003 boasts a major development in anti-IgE therapies: superior efficacy, long-acting profile that has prolonged the dosing interval from 2-4 weeks to 2-3 months and favorable security profile in comparison with Omalizumab. These benefits might present sufferers with a extra handy and efficient choice for managing allergic illnesses resembling power spontaneous urticaria (CSU), meals allergy, allergic rhinitis and bronchial asthma, which continues to vital impression public well being and high quality of life.

The meals allergy is the fourth indication of LP-003 that permitted by company. The Part III of allergic rhinitis, the section II of CSU and bronchial asthma additionally on-going. Notably, the topline results of Part II scientific trial for CSU—that includes a head-to-head comparability with omalizumab—has been accepted as a late-breaking poster by the American Academy of Allergy, Bronchial asthma & Immunology (AAAAI). The outcomes will probably be introduced on the AAAAI Annual Assembly in February 2025 in San Diego, USA.

For extra info, please go to longbio.com or contact bd@longbio.com

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