Novartis Halts Peanut Allergy Trial for Xolair's Hopeful

Novartis has decided to end its Phase III trial for ligelizumab, an investigational drug aimed at treating peanut allergies. This information was updated on ClinicalTrials.gov, but the Swiss pharmaceutical giant has yet to provide details regarding the reason for the termination. While the trial for peanut allergies has been terminated, ligelizumab remains in Novartis’ pipeline for food allergies, which is still identified as a leading indication. The company had high hopes for this drug, predicting that it could capture a market exceeding $1 billion, as reported by Endpoints News.

Ligelizumab is administered through subcutaneous injection and has been undergoing trials not only for peanut allergies but also for chronic urticaria, a persistent skin condition. Earlier in January 2023, a Phase III trial involving 39 patients for chronic inducible urticaria was also terminated. Two years prior to this, other Phase III trial failures led to the discontinuation of ligelizumab for chronic spontaneous urticaria (CSU).

Xolair, another product from Novartis, known for treating allergic asthma, chronic rhinosinusitis, and CSU, faces looming patent expirations in 2024 and 2025. As a result, Novartis and its partner Genentech are working towards obtaining new indications to extend the drug’s market viability. In December 2023, the FDA accepted a supplemental biologics license application and granted priority review to extend Xolair’s use for food allergies. If approved, Xolair could become the first treatment available for allergic reactions to multiple foods due to accidental exposure in patients as young as one year old. A decision from the FDA is expected in the first quarter of 2024.

Novartis is also focusing on remibrutinib, a BTK inhibitor, which showed positive Phase III results for treating CSU in August 2023. The drug met its primary efficacy endpoint and demonstrated rapid symptom improvement within two weeks. The company is planning to submit this data for regulatory approval within the year.

With the impending expiration of Xolair’s patents, Novartis is keen on strengthening its immunology portfolio. In 2022, Xolair generated $4 billion in global sales. In the first half of 2023 alone, the drug brought in $716 million. The company is actively seeking new avenues to bolster its offerings in the immunological space to mitigate the impact of these patent expirations.