Clinuvel Pharmaceuticals Ltd (ASX: CUV) shares are catching the eye on Tuesday.
In morning trade, the ASX healthcare stock is up almost 10% to $12.30.
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Why is this ASX healthcare stock jumping?
Investors have been buying the global specialty pharmaceuticals company's shares this morning after it released a big announcement.
According to the release, the European Medicines Agency (EMA) has agreed to amend the label for the company's photoprotective drug SCENESSE (afamelanotide).
This change will enable adult erythropoietic protoporphyria (EPP) patients to receive treatment every two months, removing the recommended maximum annual dose of four implants per year.
The company notes that this harmonises the treatment dosage in Europe with the USA, where many patients receive year-round therapy.
Why the change?
The ASX healthcare stock highlights that the EMA's Committee for Medicinal Products for Human Use (CHMP) issued its positive opinion on the benefit-risk profile of year-round SCENESSE treatment following extensive engagement with its team.
The CHMP evaluated data from two Phase III studies (CUV039 and CUV029) and real world evidence that was captured from over 15 years of SCENESSE use under compassionate, special access, and commercial programs.
The data package included a review of the safety and effectiveness profile of SCENESSE in the European patients who have received four or more implants in any one calendar year.
It notes that recognising the clinical need for EPP patients to receive year-round treatment, the committee concluded that there were no significant safety concerns with the ongoing administration of SCENESSE every two months. This variation can now be implemented immediately.
'Strong logic'
The ASX healthcare stock's chief scientific officer, Dr Dennis Wright, was pleased with the news. He said:
A decade after EMA's approval of SCENESSE we have generated a much deeper, richer pool of data helping to define the drug's benefit-risk profile, with a dossier that supports year-round patient dosing.
We have received ongoing requests from EPP expert physicians to facilitate year-round treatment in Europe and we are pleased that the CHMP's positive opinion will enable EPP patients to receive year-round treatment for this very debilitating condition. There was a strong logic to removing the maximum dose restriction in Europe, which has now been validated by the CHMP. It also harmonises the label with the USA.
Since we are administering SCENESSE in vitiligo at higher frequency of one dose every three weeks, it is obvious that both programs – EPP and vitiligo – assist us in compiling our next regulatory dossier with robust safety data.
