Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 12-15 October 2020
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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. For more information, see the press release in the grid below.
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. For more information, see the press release in the grid below.
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. For more information, see the press release in the grid below.
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. For more information, see the press release in the grid below.
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 Blincyto, Dupixent, Edistride, Forxiga, Humira, Lacosamide UCB, Opdivo, Recarbrio, Tremfya 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). For more information, see the summary of opinion document in the grid below.
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.
Agenda and minutes
The agenda of the October 2020 meeting is published on EMA's website. Minutes of the September 2020 CHMP meeting will be published in the coming weeks.
CHMP statistics
Key figures from the October 2020 CHMP meeting are represented in the graphic below.
* This product was designated as an orphan medicine during its development. Orphan designations are reviewed by EMA's Committee for Orphan Medicinal Products (COMP) at the time of approval to determine whether the information available to date allows maintaining the medicine’s orphan status and granting the medicine ten years of market exclusivity.
Positive recommendations on new medicines
| Name of medicine | Fintepla |
| International non-proprietary name (INN) | fenfluramine |
| Marketing-authorisation applicant | Zogenix ROI Limited |
| Therapeutic indication | Treatment of seizures associated with Dravet syndrome |
| More information | Fintepla: Pending EC decision |
| Name of medicine | Leqvio |
| INN | inclisiran |
| Marketing-authorisation applicant | Novartis Europharm Limited |
| Therapeutic indication | Treatment for primary hypercholesterolaemia or mixed dyslipidaemia |
| More information | Leqvio: Pending EC decision |
| Name of medicine | Libmeldy |
| INN | 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 |
| Marketing-authorisation applicant | Orchard Therapeutics (Netherlands) BV |
| Therapeutic indication | Treatment of children with the ‘late infantile’ or ‘early juvenile’ forms of metachromatic leukodystrophy |
| More information | News:New gene therapy to treat rare genetic disorder metachromatic leukodystrophy |
| Name of medicine | Oxlumo |
| INN | lumasiran |
| Marketing-authorisation applicant | Alnylam Netherlands B.V. |
| Therapeutic indication | Treatment of primary hyperoxaluria type 1 |
| More information | News:First treatment for rare condition primary hyperoxaluria type 1 |
| Name of medicine | Palforzia |
| INN | defatted powder of Arachis hypogaea L., semen (peanuts) |
| Marketing-authorisation applicant | Aimmune Therapeutics Ireland Limited |
| Therapeutic indication | Desensitisation of children and adolescents to peanut allergy |
| More information | Palforzia: Pending EC decision |
| Name of medicine | Rekambys |
| INN | rilpivirine |
| Marketing-authorisation applicant | Janssen-Cilag International N.V. |
| Therapeutic indication | Treatment of human immunodeficiency virus type-1 (HIV-1) infection in combination with cabotegravir injection |
| More information | News:First long-acting injectable antiretroviral therapy for HIV recommended for approval |
| Name of medicine | Tecartus |
| INN | autologous anti-CD19-transduced CD3+ cells |
| Marketing-authorisation applicant | Kite Pharma EU B.V. |
| Therapeutic indication | Treatment of relapsed or refractory mantle cell lymphoma |
| More information |
| Name of medicine | Trixeo Aerosphere |
| INN | formoterol / glycopyrronium bromide/ budesonide |
| Marketing-authorisation applicant | AstraZeneca AB |
| Therapeutic indication | Maintenance treatment of chronic obstructive pulmonary disease in adults whose disease is not adequately controlled |
| More information | Trixeo Aerosphere: Pending EC decision |
| Name of medicine | Vocabria |
| INN | cabotegravir |
| Marketing-authorisation applicant | ViiV Healthcare B.V. |
| Therapeutic indication | Treatment of human immunodeficiency virus type 1 (HIV-1) infection in combination with rilpivirine injection |
| More information | News:First long-acting injectable antiretroviral therapy for HIV recommended for approval |
Positive recommendation on new generic medicine
| Name of medicine | Lenalidomide Mylan |
| INN | lenalidomide |
| Marketing-authorisation applicant | Mylan Ireland Limited |
| Therapeutic indication | Treatment of multiple myeloma and follicular lymphoma |
| More information | Lenalidomide Mylan: Pending EC decision |
Positive recommendations on extensions of indications
| Name of medicine | Blincyto |
| INN | blinatumomab |
| Marketing-authorisation holder | Amgen Europe B.V. |
| More information | Blincyto: Pending EC decision |
| Name of medicine | Dupixent |
| INN | dupilumab |
| Marketing-authorisation holder | sanofi-aventis groupe |
| More information | Dupixent: Pending EC decision |
| Name of medicine | Edistride |
| INN | dapagliflozin |
| Marketing-authorisation holder | AstraZeneca AB |
| More information | Edistride: Pending EC decision |
| Name of medicine | Forxiga |
| INN | dapagliflozin |
| Marketing-authorisation holder | AstraZeneca AB |
| More information | Forxiga: Pending EC decision |
| Name of medicine | Humira |
| INN | adalimumab |
| Marketing-authorisation holder | AbbVie Deutschland GmbH & Co. KG |
| More information | Humira: Pending EC decision |
| Name of medicine | Lacosamide UCB |
| INN | lacosamide |
| Marketing-authorisation holder | UCB Pharma S.A. |
| More information | Lacosamide UCB: Pending EC decision |
| Name of medicine | Opdivo |
| INN | nivolumab |
| Marketing-authorisation holder | Bristol-Myers Squibb Pharma EEIG |
| More information | Opdivo: Pending EC decision |
| Name of medicine | Recarbrio |
| INN | imipenem / cilastatin / relebactam |
| Marketing-authorisation holder | Merck Sharp & Dohme B.V. |
| More information | Recarbrio: Pending EC decision |
| Name of medicine | Tremfya |
| INN | guselkumab |
| Marketing-authorisation holder | Janssen-Cilag International N.V. |
| More information | Tremfya: Pending EC decision |
| Name of medicine | Vimpat |
| INN | lacosamide |
| Marketing-authorisation holder | UCB Pharma S.A. |
| More information | Vimpat: Pending EC decision |
Important recommendation on new strengths, formulations or routes of administration
| Name of medicine | Plegridy |
| INN | peginterferon beta-1a |
| Marketing-authorisation holder | Biogen Netherlands B.V. |
| More information | Plegridy: Pending EC decision |
Other opinion
| Name of medicine | Desloratadine ratiopharm |
| INN | desloratadine |
| Marketing-authorisation holder | ratiopharm GmbH |
| More information | Desloratadine ratiopharm: Pending EC decision |