Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 19-22 July 2021
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Two new medicines recommended for approval
EMA’s human medicines committee (CHMP) recommended two medicines for approval at its July 2021 meeting.
The Committee adopted a positive opinion for Nexviadyme*(avalglucosidase alfa), intended for the treatment of glycogen storage disease type II (Pompe disease).
The CHMP recommended granting a marketing authorisation for the hybrid medicine Imatinib Koanaa (imatinib), intended for the treatment of leukaemia and gastrointestinal stromal tumours. Hybrid applications rely in part on the results of pre-clinical tests and clinical trials of an already authorised reference product and in part on new data.
Negative opinion on a new medicine
The CHMP adopted a negative opinion recommending the refusal of a marketing authorisation for Nouryant (istradefylline). Nouryant was intended as a medicine to treat adults with Parkinson’s disease.
For more information on this negative opinion, see the question-and-answer document in the grid below.
Four recommendations on extensions of therapeutic indication
The Committee recommended extensions of indication for Deltyba, Ultomiris, Volibris and Vosevi.
Conclusion of referral
The CHMP endorsed findings of a review, which concluded that there is no evidence that Zynteglo causes a blood cancer known as acute myeloid leukaemia (AML).
For more information, see the public health communication in the grid below.
Re-examination of recommendation on Flynpovi
The applicant for Flynpovi (eflornithine / sulindac) has requested a re-examination of the Committee’s negative opinion for this medicine adopted at its June 2021 meeting. Upon receipt of the grounds of the request, the Agency will re-examine its opinion and issue a final recommendation.
Withdrawal of application
The application to extend the use of Tecentriq (atezolizumab)to include the treatment of early or locally advanced triple-negative breast cancer was withdrawn.
A question-and-answer document on the withdrawal is available in the grid below.
Agenda and minutes
The agenda of the July 2021 CHMP meeting is published on EMA's website. Minutes of the June 2021 CHMP meeting will be published in the coming weeks.
CHMP statistics
Key figures from the July 2021 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 recommendation on new medicine
| Name of medicine | Nexviadyme |
| INN | avalglucosidase alfa |
| Marketing-authorisation applicant | Genzyme Europe BV |
| Therapeutic indication | Treatment of glycogen storage disease type II (Pompe disease) |
| More information | Nexviadyme: Pending EC decision |
Positive recommendation on new hybrid medicine
| Name of medicine | Imatinib Koanaa |
| INN | imatinib |
| Marketing-authorisation applicant | KOANAA Healthcare GmbH |
| Therapeutic indication | Treatment of leukaemia and gastrointestinal stromal tumours |
| More information | Imatinib Koanaa: Pending EC decision |
Negative recommendation on new medicine
| Name of medicine | Nouryant |
| INN | istradefylline |
| Marketing-authorisation applicant | Kyowa Kirin Holdings B.V. |
| Therapeutic indication | Treatment of Parkinson’s disease |
| More information | Nouryant: Questions and answers |
Positive recommendations on extensions of indications
| Name of medicine | Deltyba |
| INN | delamanid |
| Marketing-authorisation holder | Otsuka Novel Products GmbH |
| More information | Deltyba: Pending EC decision |
| Name of medicine | Ultomiris |
| INN | ravulizumab |
| Marketing-authorisation holder | Alexion Europe SAS |
| More information | Ultomiris: Pending EC decision |
| Name of medicine | Volibris |
| INN | ambrisentan |
| Marketing-authorisation holder | GlaxoSmithKline (Ireland) Limited |
| More information | Volibris: Pending EC decision |
| Name of medicine | Vosevi |
| INN | sofosbuvir / velpatasvir / voxilaprevir |
| Marketing-authorisation holder | Gilead Sciences Ireland UC |
| More information | Vosevi: Pending EC decision |
Conclusion of referral
| Name of medicine | Zynteglo |
| INN | betibeglogene autotemcel |
| More information | CHMP endorses review finding no link between viral vector in Zynteglo and blood cancer |
| Name of medicine | Tecentriq |
| INN | atezolizumab |
| Marketing-authorisation applicant | Roche Registration GmbH |
| More information |
Re-examination of recommendation for new medicine
| Name of medicine | Flynpovi |
| INN | eflornithine / sulindac |
| Marketing-authorisation applicant | Cancer Prevention Pharma (Ireland) Limited |
| More information | Flynpovi: Questions and answers |
Other opinions
| Name of medicine | Siklos |
| INN | hydroxycarbamide |
| Marketing-authorisation holder | Addmedica S.A.S. |
| More information | Siklos: Questions and answers |