Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 12-15 October 2020

News 16/10/2020

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.

CHMP statistics: October 2020

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

Libmeldy: Pending EC decision

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

Oxlumo: Pending EC decision

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

Rekambys: Pending EC decision

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

Tecartus: Pending EC decision

News: First CAR-T cell medicine for mantle cell lymphoma

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

Vocabria: Pending EC decision

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

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