Oasmia Pharmaceutical reports positive CHMP opinion for Apealea in EU.
M2 EQUITYBITES-September 24, 2018-Oasmia Pharmaceutical reports positive CHMP opinion for Apealea in EU
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Oasmia Pharmaceutical AB (STO:OASM) announced on Friday that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending approval of Apealea in combination with carboplatin, to treat adult patients with first relapse of platinum-sensitive epithelial ovarian cancer, primary peritoneal cancer and fallopian tube cancer.
Reportedly, the CHMP has considered that the product Apealea in combination with carboplatin has a positive benefit-risk balance and is considered approvable for the above-mentioned indication.
This CHMP positive opinion will now be considered by the European Commission. In the event that the CHMP opinion is affirmed, the European Commission will grant a centralised marketing authorisation with unified labelling that is valid in 28 countries of the European Union (EU), as well as the European Economic Area members, Iceland, Lichtenstein and Norway.
According to the company, the CHMP recommendation is based on clinical trials including the pivotal study OAS 07OVA. This study showed that the risks of disease progression or death after Apealea treatment in combination with carboplatin are similar as after Cremophor EL (CrEL)-formulated paclitaxel in combination with carboplatin.
Oasmia Pharmaceutical develops, manufactures, markets and sells new generations of drugs in the field of human and veterinary oncology.
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|Publication:||M2 EquityBites (EQB)|
|Date:||Sep 24, 2018|
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