Lobsor Pharmaceuticals has announced that Lecigon has been approved, and that the Swedish Medical Products Agency (MPA) has confirmed End of Procedure according to the European Mutual Recognition Procedure (MRP) including Denmark, Finland and Norway.
“We are delighted to have now received confirmation of End of Procedure, particularly since it came two months earlier than expected,” says Ulf Rosén, Co-founder of Lobsor.
The national phase is expected to be finalized end of October 2019
The approval follows the Swedish marketing authorization for Lecigon which was granted in October 2018. Immediately after the MRP Approval, the procedure enters a national phase for approval of labels, package inserts etc. in the local language. The national phase is expected to be finalized end of October 2019 when the national market authorizations can be granted, and subsequent commercialization initiated.
“The positive outcome underscores our commitment to providing widespread patient access to this treatment “, continues Rosén. “We will seek additional European approvals via the MRP procedure over the next 18 months.”
Photo of Ulf Rosén: Lobsor Pharmaceuticals