Regulatory spotlight: Novartis’s remibrutinib likely to progress after positive urticaria trial

Urticaria is defined as a skin lesion consisting of a wheal-and-flare reaction in which localized intracutaneous edema is surrounded by an area of redness that is typically pruritic. Individual hives can last as briefly as 30 minutes to as long as 36 hours.

After positive Phase IIb data were reported, Novartis's remibrutinib saw a six-point increase in its Phase Transition Success Rate (PTSR) for chronic, spontaneous urticaria (CSU). The probability, expressed as a percentage, that a drug will successfully complete each stage of development is known as PTSR. On September 30, the 311-patient Phase IIb trial's (NCT03926611) outcomes were made public. On October 4, the PTSR of Remibrutinib was updated to 55%.

Hives are a more common name for urticaria. Remibrutinib's dose-response improvement over placebo in the primary endpoint change from baseline in the weekly Urticaria Pipeline Drugs Market at week 4 was statistically significant. Patients with inadequate antihistamine symptom control were recruited for the study. BTK inhibitor remibrutinib is taken orally.

Due to favorable Phase IIb data, Remibrutinib's Likelihood of Approval (LoA) also increased by three points to 31%. GlobalData's analysis employs a combination of machine learning and its own proprietary algorithm to identify LoA. A drug's LoA and PTSR can be calculated by taking factors like therapy area, indication, and molecule type into account.


richardwilliam93

5 Blog posts

Comments