Novartis (NVS) said Friday that the European Medicines Agency's Committee for Medicinal Products for Human Use has recommended marketing authorization for remibrutinib as an oral treatment for chronic spontaneous urticaria in adults with inadequate response to H1-antihistamines.

The European Commission is expected to act on the CHMP's positive opinion and issue a decision in about two months, the company said.

The CHMP recommendation was backed by results from two phase 3 trials in which remibrutinib showed improvements in itch and hives as early as the first week, with benefits sustained for 52 weeks, Novartis said.

The drug also showed improvements in quality of life and sleep and a favorable safety profile, the company said.

Chronic spontaneous urticaria refer to hives that last for six weeks or longer, and are caused by no external trigger or allergen.

Shares of Novartis were up 1.8% in recent premarket activity Friday.