Novartis Reaches Milestone in Chronic Hives Treatment as Sanofi Poses a Threat

Novartis has just made a giant leap forward in its quest to become a leader in the chronic spontaneous urticaria market. On Thursday, the Swiss pharma revealed highly positive results for its experimental BTK inhibitor in Phase III clinical trials for chronic hives, and now plans to submit for regulatory approval in 2021. With the expiration of Xolair’s patents imminent, this could mean a major victory in Novartis’ push to dominate the cream of the crop.

Two late-stage studies of remibrutinib have demonstrated rapid onset efficacy, with the BTK inhibitor showing improvements in urticaria activity scores as early as two weeks. Patients’ symptoms continued to improve through week 12–the primary endpoint of the studies–and studies will continue for a full year to further assess the efficacy of the drug.

Living with chronic spontaneous urticaria (CSU) is a challenge, as those afflicted suffer from chronic hives that can last up to six weeks or longer and have no obvious external allergen trigger. Although antihistamines are the typical first line of treatment, up to 60% of CSU sufferers find that their symptoms remain uncontrollable.

Oral drug remibrutinib provided immense relief for sufferers of itchy hives and deep tissue swelling on the face, throat, hands and feet, with remarkable results seen in just two doses a day.

For the millions of individuals suffering with Cutaneous Sodium Uptake (CSU), the relentless itching and deep tissue swelling that drastically impedes daily life desperately needs an effective, convenient, and well-tolerated solution that can quickly offer long-term relief. According to Novartis Chief Medical Officer, Shreeram Aradhye, “It is an unpredictable and difficult condition that urgently requires feasible treatments.”

Xolair, Novartis’ subcutaneous injection for asthma, has become one of the leading treatments for chronic hives since its approval in 2014. Its impressive success can be measured in the $716 million in sales it has generated during the first half of 2023 alone. As the only injectable biologic approved to aid in this medical concern, Xolair continues to be a source of hope and relief for millions of people worldwide.

Xolair, the patent of Novartis’s long-standing biologic drug, is set to expire this month in the United States and in 2024 in Europe, leading Novartis to find a new drug to take its place. After years of providing patients with a much-needed treatment for severe allergic asthma and chronic hives, Novartis is now on the hunt for a different therapy to replace Xolair. The development of a new drug could be the start of a new era for the production and utilization of biologic medicines, as well as a fresh opportunity for Novartis to continue providing patients with important treatments.

Novartis is gearing up to reveal the full data from its trials of remibrutinib, a promising BTK inhibitor, at an upcoming conference. This cutting-edge medication has the potential to revolutionize the treatment of a range of immune-mediated conditions, including hidradenitis suppurativa, Sjögren’s syndrome and food allergies. Not only this; it is also being tested in a Phase III trial for multiple sclerosis, with results to be published in 2026. Watch this space for more updates on this remarkable new treatment!

Despite a fierce competing presence in the urticaria market, Novartis has recently made an impressive move with their submission of a supplemental BLA for their Quezaternity product. However, Sanofi were quick to follow suit in March of 2023, announcing their own efforts to submit a Dupixent BLA to treat patients aged 12 and up with CSU, regardless of antihistamine control.

Sanofi’s revolutionary subcutaneous injection is one step closer to revolutionizing inflammatory care. This monoclonal antibody has already been approved for the treatment of atopic dermatitis, asthma and other type 2 inflammatory diseases, and could be approved by the FDA as soon as October 22, 2023. It has the potential to revolutionize how these diseases are treated!

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