Advanced therapy medicinal product for melanoma receives positive opinion
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended an advanced therapy medicine for marketing authorisation at its October 2015 meeting.
Imlygic (talimogene laherparepvec) is a medicine for the treatment of adults with melanoma that cannot be removed by surgery and that has spread either to the surrounding area or to other areas of the body without affecting the bones, brain, lung or other internal organs. Imlygic is a first-in-class advanced therapy medicinal product (ATMP) derived from a virus that has been genetically engineered to infect and kill cancer cells. For more information on Imlygic, please see the press release in the grid below.
Seven recommendations on extensions of therapeutic indication
The Committee recommended extensions of indication for Cubicin, Edurant, Emend,Volibris, Xalkori and two extensions of indication for Cosentyx.
Re-examination procedure concluded
The CHMP concluded a re-examination procedure, issuing a final negative opinion for Heparesc (human heterologous liver cells). A question-and-answer document on this opinion is available below.
Inductos to be suspended in the EU
The Committee recommended the suspension of Inductos, an implant used to help new bone develop in patients with spinal disc problems and leg fractures, due to manufacturing issues. Although no risk to patients has been identified, Inductos will remain suspended until issues with the manufacturing site for one of its components (an absorbable sponge) are resolved. For more information, please see the public health communication in the grid below.
Outcome of periodic safety review: Cellcept
The CHMP warned that the transplant medicine mycophenolate (authorised centrally as CellCept and nationally under various names) must not be used in pregnancy unless no alternative is available. This follows a routine re-assessment of the benefits and risks of these medicines, which provided updated evidence on the risk of birth defects and spontaneous abortions when pregnant women were exposed to these medicines. For more information, please see the public health communication in the grid below.
New advice for doctors and patients on Tecfidera
The CHMP gave new advice for doctors and patients to minimise the risk of progressive multifocal leukoencephalopathy (PML) in patients treated with the multiple sclerosis medicine Tecfidera (dimethyl fumarate). For more information, please see the public health communication in the grid below.
Update to safety information for medicines for the treatment of HIV infection
The CHMP has updated the advice on the risk of body fat changes and lactic acidosis with medicines for the treatment of human immunodeficiency virus (HIV) infection. As a result, HIV medicines will no longer require a warning concerning fat redistribution in their product information, and a number of medicines of the class ‘nucleoside and nucleotide analogues’ will no longer require a warning about lactic acidosis. For more information, please see the public health communication in the grid below.
Withdrawal of application
An application for marketing authorisation for VeraSeal (human fibrinogen / human thrombin) has been withdrawn. A question-and-answer document on this withdrawal is available below.
Posted on the EMA website on 23 October 2015