2021-04-14| Trials & Approvals

Novartis, Genentech Bag Key FDA Okay for Blockbuster Drug

by Rajaneesh K. Gopinath
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Novartis and Genentech have won a key FDA approval that could help their blockbuster drug, Xolair gain a few paces ahead of its competitors. On April 13th, the companies announced that the FDA has approved their supplemental BLA for Xolair prefilled syringe for self-injection.

Xolair (omalizumab) is an IgE targeting monoclonal antibody that reduces allergic symptoms. It is FDA-approved for three major indications; moderate-to-severe Asthma, Chronic Idiopathic Urticaria (CIU), and Nasal Polyps. Currently, it is the only FDA-approved biologic designed to target and block IgE for treating these indications. First launched as a sterile lyophilized powder that had to be reconstituted for injection, Xolair gained FDA approval for prefilled syringe formulation in 2018. Prior to the latest approval for self-injection, the drug could be administered only in a healthcare setting by a licensed provider.

Only patients who do not have a prior history of anaphylaxis and have received at least three injections of Xolair by a provider without exhibiting allergic reactions could be eligible for self-injection. As per FDA guidelines, the drug treatment must be initiated and safely established in a healthcare setting, following which a provider can recommend self-injection either by the patient themselves or a caregiver.

“Today’s FDA approval represents an important milestone for Xolair and highlights our continued commitment to innovation for patients since its first approval in 2003,” said Victor Bultó, President, Novartis Pharmaceuticals Corporation. “With the new offering of self-injection for Xolair, healthcare providers now have an additional administration option for appropriate patients, which is particularly timely given the COVID-19 pandemic.”



Xolair is a blockbuster drug that currently faces stiff competition from Sanofi and Regeneron’s Dupixent in two indications and counting. Besides, a number of Xolair biosimilars are in the pipeline, namely Glenmark Pharmaceuticals’ GBR 310, Sorrento Therapeutics/MabTech’s STI-004, Celltrion Healthcare’s CT-P39, and BiosanaPharma’s BP001. The regulatory win for self-injection will give Novartis and Genentech a slight advantage from the contest.

To deal with the competition, Novartis is advancing a much potent anti-IgE monoclonal antibody, ligelizumab, an asset it acquired from Ziarco Group Limited. Ligelizumab has already bagged the FDA’s breakthrough therapy designation for treating CIU. For its part, Genentech, a Roche subsidiary, is also evaluating Fenebrutinib, a small molecule inhibitor of Bruton’s tyrosine kinase (BTK) in CIU.

“Today’s approval reflects our commitment to continued innovation with Xolair to address the critical needs of people living with allergic and inflammatory conditions,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer, and Head of Global Product Development. “Appropriate patients will now have the flexibility to administer Xolair from home, which is particularly important for those who are considered high-risk during the COVID-19 pandemic.”

Related Article: Gilead’s Breast Cancer Drug that Came off a $21 Billion Buyout Finally Gets FDA’s Full Approval



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