Recordati announces completion of MRP for antihypertensive drug

Recordati has announced that the mutual recognition process (MRP) for drug approval throughout the EU, Norway and Iceland has been completed for its new antihypertensive drug based on a fixed lercanidipine and enalapril combination.

Germany acted as the reference member state for the process, with the German medicines agency granting approval for the drug in its two available dosage firms in 2006 and the drug being on the market in that country from 2007.

The other member states have now decided to recognise this approval, with Recordati forecasting that fixed combinations of antihypertensive agents will play an increasingly important role in the market to treat hypertension patients.

Giovanni Recordati, chairman and chief executive officer of Recordati, said: “We are very pleased to be able to announce the positive outcome of the mutual recognition process for the approval of our new antihypertensive specialty throughout Europe.”

He added that the company will launch the compound in all member states, with this extension of its therapeutic offering permitting the company to enhance its position in the market for antihypertensive medication.

Earlier this month, Recordati announced that it had signed an agreement to purchase two pharmaceutical plants as part of its expansion plans in Europe.