The European approval is based on Phase 3 data from the SUNSHINE and SUNRISE trials which enrolled more than 1,000 patients in 40 countries for short and long term
A image of the laboratory building on the Novartis Campus. (Credit: Novartis AG)
Novartis announced that its Cosentyx (secukinumab) has been approved by the European Commission (EC) to treat adult patients with active moderate to severe hidradenitis suppurativa (HS) and showed an inadequate response to traditional systemic HS therapy.
Cosentyx is said to be the first and only fully human biologic that directly inhibits interleukin-17A cytokine.
The European approval is based on Phase 3 data from the SUNSHINE and SUNRISE trials. Both studies enrolled more than 1,000 patients in 40 countries.
SUNSHINE and SUNRISE trials assessed the short- (16 weeks) and long-term (52 weeks) efficacy, safety and tolerability of two dose regimens of Cosentyx in adults with moderate to severe HS.
According to the results published in The Lancet, the treatment response rates in patients randomised to Cosentyx improved beyond the primary endpoint analysis at Week 16.
The findings showed that more than 55% of patients achieved the primary endpoint of a Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 52.
Novartis, a Swiss pharmaceutical company, said that the safety profile was like that of Cosentyx in its other indications.
Novartis Europe president Haseeb Ahmad said: “Since its first approval in 2015, Cosentyx has been used to treat more than 1 million people worldwide. We are pleased to bring Cosentyx as a much-needed and trusted treatment option that brings rapid and sustained symptom relief to HS patients.
“With established market access and patient support programs, Novartis is in a strong position to support fast and widespread access to Cosentyx. This milestone approval is a major step forward in our ambition to deliver quality medicines that alleviate major unmet medical needs.”
The company is also expecting a regulatory decision from the US Food and Drug Administration (FDA) later this year.
In a separate development, Sandoz, a former unit of Novartis, announced its plans to shift to a new central Basel headquarters by June 2024.
The future permanent headquarters will be located at an office building called in the centre of Basel, right by the Basel SBB train station. The plan aligns with Sandoz’s commitment to Basel following its proposed separation from Novartis in the second half of 2023.