Novartis (NVS) suffered a setback when the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (:EMA) issued a negative opinion on pipeline candidate RLX030 (serelaxin).
Novartis was seeking approval of RLX030 for the treatment of acute heart failure (:AHF). Novartis now plans to submit a revised filing package for obtaining conditional marketing approval in the EU.
Novartis expects a revised opinion by the second quarter of 2014. The supporting data and analysis submitted by Novartis was not sufficient to grant full approval.
Meanwhile, RLX030 is under review in the U.S. We remind investors that RLX030 was granted a Breakthrough Therapy designation status in the U.S. in Jun 2013. Novartis is expected to present efficacy and safety data at the Food and Drug Administration (:FDA)'s Cardiovascular and Renal Drugs Advisory Committee meeting in Feb 2013 to discuss a potential approval.
On the other hand, Novartis received encouraging news when the CHMP granted a positive opinion for the use of Xolair as an add-on therapy for the treatment of chronic spontaneous urticaria (CSU) in adults and adolescents (12 years and above) patients with inadequate response to H1 antihistamine treatment.
The CHMP opinion was based on positive results from three pivotal phase III registration studies (ASTERIA I, ASTERIA II and GLACIAL). Xolair met all primary and pre-specified secondary endpoints across these studies. The studies showed that Xolair significantly improved itch and hives, including rapid itch relief, and in many cases completely cleared symptoms.
We expect an approval for the CSU indication within two months as the European Commission generally follows the recommendations of the CHMP.
We remind investors that Xolair is approved in the U.S. for the treatment of moderate-to-severe persistent allergic asthma in adolescents (aged 12 and above) and adults. In the EU, Xolair is approved for severe persistent allergic asthma in children (aged six and above), adolescents, and adults. We note that Roche (RHHBY) markets Xolair in the U.S.
However, we were disappointed by the negative opinion by CHMP for RLX030 and expect investor focus to remain on further updates on a revised filing in the EU. We look forward to the data presentation on RLX030 for a potential approval in the U.S.