Photo courtesy of Celgene
Lenalidomide (Revlimid)
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended approval for Lenalidomide Accord as a treatment for multiple myeloma (MM).
Lenalidomide Accord is a generic version of the immunomodulatory agent Revlimid, which has been authorized in the European Union since June 2007.
The CHMP said studies have demonstrated the satisfactory quality of Lenalidomide Accord and its bioequivalence to Revlimid.
The CHMP’s recommendation for Lenalidomide Accord will be reviewed by the European Commission, which has the authority to approve medicines for use in the European Union, Norway, Iceland, and Liechtenstein.
The European Commission usually makes a decision within 67 days of the CHMP’s recommendation.
If approved, Lenalidomide Accord will be available as capsules (2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg, and 25 mg) and authorized for the following uses:
- As monotherapy for the maintenance treatment of adults with newly diagnosed MM who have undergone autologous stem cell transplant
- In combination with melphalan and prednisone followed by lenalidomide maintenance in adults with previously untreated MM who are not eligible for transplant
- In combination with dexamethasone to treat MM in adults who have received at least 1 prior therapy.
The applicant for Lenalidomide Accord is Accord Healthcare Limited.