The European Medicines Agency initiated a review of Leo Pharma A/S' Picato gel to treat a skin condition caused by excessive exposure to sunlight.
Several studies show that patients using the gel to treat actinic keratosis, a crusty and scaly growth on the skin, had a higher number of skin cancer cases, the European regulator noted in its Sept. 6 release.
The EMA's Pharmacovigilance Risk Assessment Committee will review all available data and recommend a decision whether or not to approve the product in the EU, where it was approved for sale in November 2012.
The recommendation will be forwarded to the agency's Committee for Medicinal Products for Human Use. The review will be completed after the European Commission adopts a legally binding decision applicable in all EU member states.
The U.S. Food and Drug Administration approved Picato for actinic keratosis on the face, scalp, trunk and extremities in January 2012.
Dublin-based Perrigo Co. PLC also received FDA tentative approval to market a generic version of Picato gel 0.05% in November 2017. In September 2018, Perrigo settled a lawsuit regarding its generic version with Leo Pharma.
The EU agency also cautioned healthcare professionals about using the gel in patients with a history of skin cancer. Users are advised to look out for any skin lesions and immediately report any abnormality to a physician.
