Bayer’s Diane-35 back on French market

Following the confirmation of the positive benefit-risk profile by the European Medicines Agency, German drug major Bayer (BAYN: DE) says it is reintroducing its acne drug Diane-35 (cyproterone acetate 2mg, ethinylestradiol 35mcg) onto the French market in agreement with the French health authority (ANSM).

The product had been withdrawn from the French market after a suspension of the marketing authorization as required by the ANSM in May 2013. Diane-25 was never a major product for Bayer, generating global sales of just 194 million euros ($265 million) in 2012.

Based on the request of the ANSM at the beginning of 2013, the EMA conducted a review of the benefit-risk profile of Diane-35 and its generics. At the end of July 2013, the EMA concluded that the benefits of Diane-35 outweighed the risks for the treatment of moderate to severe acne related to androgen sensitivity and/or hirsutism (excessive unwanted growth of hair in women) in women of reproductive age. However, when used for acne, Diane-35 should only be used if other treatments, such as those applied to the skin and antibiotics, have failed.

Bayer has collaborated closely with the ANSM in order to ensure a proper handling of the medicine and will continue to do so.