Pliaglis regulatory update

Nuvo said the German Federal Institute for Drugs and Medical Devices (BfArM) recommended approval of Pliaglis lidocaine/tetracaine to produce local anesthesia on intact skin in adults prior to superficial dermatological procedures. The MAA for Pliaglis is being reviewed under the EU's decentralized procedure, with Germany acting as the reference member state. Nuvo is eligible to receive up to $6 million in milestones related to specific market launches from partner Galderma S.A. (Lausanne, Switzerland).

Separately, Nuvo said Galderma submitted a response to an April complete response letter from FDA for an sNDA for Pliaglis for the indication (see BioCentury, April 23). Nuvo said it expects a 4-month review. The response includes information on the manufacturing transfer of Pliaglis from a third-party manufacturer to Galderma's manufacturing facility. The response also includes stability data and proposed label revisions. FDA approved the phase-changing topical formulation of lidocaine and tetracaine for the indication in 2006, but Galderma voluntarily removed the product from the market in 2008 due to issues with the contract manufacturer. ...