Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 21-24 February 2022

News 25/02/2022

EMA’s human medicines committee (CHMP) recommended thirteen medicines for approval at its February 2022 meeting.

The CHMP gave a positive opinion for Kimmtrak* (tebentafusp) for the treatment of uveal melanoma, a type of eye cancer. Kimmtrak was reviewed under EMA’s accelerated assessment programme. See more details in the news announcement in the grid below.

PreHevbri (Hepatitis B vaccine (recombinant, adsorbed)) was granted a positive opinion for the active immunisation against hepatitis B virus infection.

A positive opinion was adopted for Kapruvia (difelikefalin) for the treatment of moderate-to-severe pruritus associated with chronic kidney disease.

Orgovyx (relugolix) received a positive opinion from the CHMP for the treatment of prostate cancer.

The Committee gave a positive opinion for Quviviq (daridorexant) for the treatment of insomnia.

A positive opinion was adopted for Vydura (rimegepant) for the prophylaxis and acute treatment of migraine.

Two biosimilar medicines were recommended for approval: Inpremzia (insulin human (rDNA)) and Truvelog Mix 30 (insulin aspart), both for the treatment of diabetes mellitus.

Five generic medicines received a positive opinion from the Committee: Dimethyl fumarate Mylan (dimethyl fumarate), Dimethyl fumarate Neuraxpharm (dimethyl fumarate) and Dimethyl fumarate Polpharma (dimethyl fumarate), all for the treatment of adult patients with relapsing remitting multiple sclerosis; Amversio (betaine anhydrous) for the treatment of homocystinuria; and Sitagliptin Accord (sitagliptin) for the treatment of type 2 diabetes mellitus.

Recommendations on extensions of therapeutic indication for seven medicines

The Committee recommended a total of nine extensions of indication for medicines that are already authorised in the European Union (EU). These include Beovu, Delstrigo, Pifeltro, Verzenios and Yervoy, as well as Opdivo, for which the CHMP adopted three therapeutic extensions. It also includes an extension of the use of the COVID-19 vaccine Spikevax to children from 6-11 years of age. More information on this extension is available below and in a separate news announcement.

Re-examinations

Following a re-examination, the CHMP confirmed its original recommendation to refuse the granting of a marketing authorisation for Ipique (bevacizumab). This medicine was intended to treat neovascular (wet) age-related macular degeneration. For more information on this re-examination opinion, see the question-and-answer document in the grid below.

The applicant for Aduhelm (aducanumab), intended for the treatment of Alzheimer’s disease, requested a re-examination of the Committee’s December 2021 opinion not to grant a marketing authorisation.

The marketing authorisation holder for Tecfidera (dimethyl fumarate) requested a re-examination of EMA’s January 2022 opinion.

The re-examination procedures for both medicines will start upon receipt of the grounds for the requests, at the end of which the Agency will issue a final recommendation.

Readopted opinion

The Committee adopted a revised opinion for Padcev (enfortumab vedotin) after further safety information emerged during the decision-making process. Following a request from the European Commission, the CHMP readopted its opinion, taking into account the latest information.

COVID-19 updates

The CHMP recommended that a booster dose of the COVID-19 vaccine Comirnaty (tozinameran) may be given, where appropriate, to adolescents from 12 years of age. More details are available in a separate news announcement.

The Committee recommended granting an extension of indication for Spikevax (COVID-19 mRNA vaccine (nucleoside-modified)) to include the use of this COVID-19 vaccine in children aged 6 to 11. More details are available in a separate news announcement.

The CHMP also recommended including the use of Spikevax as a booster dose in people who have previously completed a primary vaccination with another mRNA vaccine or an adenoviral vector vaccine.

An increase in manufacturing capacity for COVID-19 vaccine Spikevax was approved by the CHMP.

Agenda and minutes

The agenda of the February 2022 CHMP meeting is published on EMA's website. Minutes of the January 2022 CHMP meeting will be published in the coming weeks.

CHMP statistics

Key figures from the February 2022 CHMP meeting are represented in the graphic below.

CHMP highlights February 2022


*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 Kapruvia
International non-proprietary name (INN) difelikefalin
Marketing-authorisation applicant Vifor Fresenius Medical Care Renal Pharma France
Therapeutic indication Treatment of moderate-to-severe pruritus associated with chronic kidney disease
More information Kapruvia: Pending EC decision

Name of medicine Kimmtrak
INN tebentafusp
Marketing-authorisation applicant Immunocore Ireland Limited
Therapeutic indication Treatment of uveal melanoma
More information

Kimmtrak: Pending EC decision

News announcement: New medicine for rare type of eye cancer

Name of medicine Orgovyx
INN relugolix
Marketing-authorisation applicant Myovant Sciences Ireland Limited
Therapeutic indication Treatment of prostate cancer
More information Orgovyx: Pending EC decision

Name of medicine PreHevbri
Common name Hepatitis B vaccine (recombinant, adsorbed)
Marketing-authorisation applicant VBI Vaccines B.V.
Therapeutic indication Active immunisation against hepatitis B virus infection
More information PreHevbri: Pending EC decision

Name of medicine Quviviq
INN daridorexant
Marketing-authorisation applicant Idorsia Pharmaceuticals Deutschland GmbH
Therapeutic indication Treatment of insomnia
More information Quviviq: Pending EC decision

Name of medicine Vydura
INN rimegepant
Marketing-authorisation applicant Biohaven Pharmaceutical Ireland DAC
Therapeutic indication Prophylaxis and acute treatment of migraine
More information Vydura: Pending EC decision

Positive recommendations on new biosimilar medicines

Name of medicine Inpremzia
INN insulin human (rDNA)
Marketing-authorisation applicant Baxter Holding B.V.
Therapeutic indication Treatment of diabetes mellitus
More information Inpremzia: Pending EC decision

Name of medicine Truvelog Mix 30
INN insulin aspart
Marketing-authorisation applicant sanofi-aventis groupe
Therapeutic indication Treatment of diabetes mellitus
More information Truvelog Mix 30: Pending EC decision

Positive recommendations on new generic medicines

Name of medicine Amversio
INN betaine anhydrous
Marketing-authorisation applicant SERB SA
Therapeutic indication Treatment of homocystinuria
More information

Name of medicine Dimethyl fumarate Mylan
INN dimethyl fumarate
Marketing-authorisation applicant Mylan Ireland Limited
Therapeutic indication Treatment of adult patients with relapsing remitting multiple sclerosis
More information Dimethyl fumarate Mylan: Pending EC decision

Name of medicine Dimethyl fumarate Neuraxpharm
INN dimethyl fumarate
Marketing-authorisation applicant Laboratorios Lesvi S.L.
Therapeutic indication Treatment of adult patients with relapsing remitting multiple sclerosis
More information Dimethyl fumarate Neuraxpharm: Pending EC decision

Name of medicine Dimethyl fumarate Polpharma
INN dimethyl fumarate
Marketing-authorisation applicant Zakłady Farmaceutyczne Polpharma S.A.
Therapeutic indication Treatment of adult patients with relapsing remitting multiple sclerosis
More information Dimethyl fumarate Polpharma: Pending EC decision

Name of medicine Sitagliptin Accord
INN sitagliptin
Marketing-authorisation applicant Accord Healthcare S.L.U.
Therapeutic indication Treatment of type 2 diabetes mellitus
More information Sitagliptin Accord: Pending EC decision

Re-examination of initial application following negative opinion

Name of medicine Aduhelm
INN aducanumab
Marketing-authorisation applicant Biogen Netherlands B.V.
Therapeutic indication Treatment of Alzheimer’s disease
More information Aduhelm: Questions and answers

Positive recommendations on extensions of indications

Name of medicine Beovu
INN brolucizumab
Marketing-authorisation holder Novartis Europharm Limited
More information Beovu: Pending EC decision

Name of medicine Delstrigo
INN doravirine / lamivudine / tenofovir disoproxil
Marketing-authorisation holder Merck Sharp & Dohme B.V.
More information Delstrigo: 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 Pifeltro
INN doravirine
Marketing-authorisation holder Merck Sharp & Dohme B.V.
More information Pifeltro: Pending EC decision

Name of medicine Spikevax
INN COVID-19 mRNA vaccine (nucleoside-modified)
Marketing-authorisation holder Moderna Biotech Spain, S.L.
More information

Spikevax (previously COVID-19 Vaccine Moderna): Pending EC decision

News announcement: EMA recommends approval of Spikevax for children aged 6 to 11 (24/02/2022)

Name of medicine Verzenios
INN abemaciclib
Marketing-authorisation holder Eli Lilly Nederland B.V.
More information Verzenios: Pending EC decision

Name of medicine Yervoy
INN ipilimumab
Marketing-authorisation holder Bristol-Myers Squibb Pharma EEIG
More information Yervoy: Pending EC decision

Readopted opinion

Name of medicine Padcev
INN enfortumab vedotin
Marketing-authorisation applicant Astellas Pharma Europe B.V.
Therapeutic indication Treatment of locally advanced or metastatic urothelial cancer
More information Padcev: Pending EC decision

Re-examination of extension of indication

Name of medicine Tecfidera
INN dimethyl fumarate
Marketing-authorisation holder Biogen Netherlands B.V.
More information Tecfidera: Pending EC decision

Outcome of re-examination

Name of medicine Ipique
INN bevacizumab
Marketing-authorisation holder Rotterdam Biologics B.V.
More information Ipique: Pending EC decision

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