Ten new medicines recommended for approval

EMA’s human medicines committee (CHMP) recommended ten medicines for approval at its October 2020 meeting.

The Committee recommended granting a conditional marketing authorisation for Tecartus* (autologous anti-CD19-transduced CD3+ cells) for the treatment of adult patients with a rare cancer of white blood cells called mantle cell lymphoma. Since Tecartus addresses an unmet medical need, it benefited from support within the PRIME scheme, EMA’s platform for early and enhanced dialogue with developers of promising new medicines.

The CHMP recommended granting a marketing authorisation for the gene therapy Libmeldy* (autologous CD34+ cell enriched population that contains hematopoietic stem and progenitor cells transduced ex vivo using a lentiviral vector encoding the human arylsulfatase A gene) to treat metachromatic leukodystrophy (MLD). MLD is a rare inherited metabolic disease that affects the nervous system and causes the progressive loss of motor function and cognitive ability and, ultimately, death. There is currently no cure for MLD.

The Committee recommended granting a marketing authorisation for Oxlumo* (lumasiran), for the treatment of primary hyperoxaluria type 1, a rare inherited disorder. Oxlumo was accepted in EMA’s PRIME scheme and has benefited from the extra support offered by the Agency to medicines that have a particular potential to address patients’ unmet medical needs. The CHMP reviewed the application for Oxlumo under its accelerated assessment procedure.

EMA has recommended the granting of marketing authorisations for two new antiretroviral (ARV) medicines, Rekambys (rilpivirine) and Vocabria (cabotegravir), to be used together for the treatment of human immunodeficiency virus type 1 (HIV-1) infection. The two medicines are the first ARVs that come in a long-acting injectable formulation.

Fintepla* (fenfluramine) received a positive opinion for the treatment of seizures associated with Dravet syndrome.

The CHMP recommended granting a marketing authorisation for Leqvio (inclisiran), for the treatment of primary hypercholesterolaemia or mixed dyslipidaemia.

Palforzia (defatted powder of Arachis hypogaea L., semen (peanuts)) received a positive opinion from the Committee for desensitising children and adolescents to peanut allergy.

The CHMP adopted a positive opinion for Trixeo Aerosphere (formoterol / glycopyrronium bromide / budesonide), for the maintenance treatment of chronic obstructive pulmonary disease in adults whose disease is not adequately controlled.

The Committee recommended granting a marketing authorisation for the generic medicine Lenalidomide Mylan (lenalidomide), for the treatment of multiple myeloma and follicular lymphoma.

Ten recommendations on extensions of therapeutic indication

The Committee recommended extensions of indication for BlincytoDupixentEdistrideForxigaHumiraLacosamide UCBOpdivoRecarbrioTremfya and Vimpat.

The CHMP also recommended the addition of a new route of administration (intramuscular use) for Plegridy.

Change to non-prescription status

The CHMP recommended a change in classification status from prescription to non-prescription for Desloratadine ratiopharm (desloratadine).

EU regulators request nitrosamine testing of metformin medicines

EMA and EU national competent authorities will be contacting all marketing authorisation holders of metformin-containing medicines, used for the treatment of diabetes, to request they implement testing of the medicines for the presence of nitrosamines before they are released onto the market.

This is a precautionary step to ensure patient safety while ongoing investigations on these medicines are being finalised. The request is in line with this year’s Article 5(3) review, which introduced measures required of companies to limit the presence of nitrosamines in medicines. Regulatory authorities will carefully monitor the responses to this request and take appropriate action where necessary.

The presence of nitrosamine in metformin medicines is under ongoing investigation since a nitrosamine called N-nitrosodimethylamine (NDMA) was found in some EU batches earlier this year. For more information, please see our website.

EMA advises patients in the EU to continue to take metformin medication as the risks from not treating diabetes far outweigh any possible effects of the low levels of NDMA seen in tests.

Although NDMA is classified as a probable human carcinogen (a substance that could cause cancer) on the basis of animal studies, it is not expected to cause harm when ingested in very low levels.

EMA and national authorities will continue to provide updates as necessary.

Posted on the EMA website on 16 October 2020