LEO Pharma gets FDA nod for Picato

Independent Danish drugmaker LEO Pharma says that the US Food and Drug Administration has approved its Picato (ingenol mebutate) gel (0.015%, 0.05%) as a treatment for actinic keratoses (AK) on the face, scalp, trunk and extremities.

This is LEO’s first major US approval in around 20 years and an advance in terms of speed of treatment (two to three days compared to several weeks or months). The company expects Picato to be available to US physicians in March 2012.

Picato gel is a once-daily, field-directed topical treatment for AK, a potential precursor to non-melanoma skin cancer caused by cumulative sun exposure. Treatment with Picato gel is completed over two consecutive days for AK on the trunk and extremities and over three consecutive days on the face and scalp.