Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 21-24 February 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.
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 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.
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.
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
Key figures from the February 2022 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.
|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||Dimethyl fumarate Neuraxpharm|
|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||Spikevax|
|INN||COVID-19 mRNA vaccine (nucleoside-modified)|
|Marketing-authorisation holder||Moderna Biotech Spain, S.L.|
News announcement: EMA recommends approval of Spikevax for children aged 6 to 11 (24/02/2022)
- Amversio: EPAR
- Beovu: EPAR
- Delstrigo: EPAR
- Dimethyl fumarate Mylan: EPAR
- Dimethyl fumarate Neuraxpharm: EPAR
- Dimethyl fumarate Polpharma: EPAR
- Inpremzia: EPAR
- Ipique: EPAR
- Kapruvia: EPAR
- Kimmtrak: EPAR
- Opdivo: EPAR
- Orgovyx: EPAR
- Padcev: EPAR
- Pifeltro: EPAR
- PreHevbri: EPAR
- Quviviq: EPAR
- Sitagliptin Accord: EPAR
- Spikevax (previously COVID-19 Vaccine Moderna): EPAR
- Tecfidera: EPAR
- Truvelog Mix 30: EPAR
- Verzenios: EPAR
- Vydura: EPAR
- Yervoy: EPAR