Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 24-27 June 2019
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Three new medicines recommended for approval
EMA’s human medicines committee (CHMP) recommended three medicines for approval at its June 2019 meeting.
The Committee recommended granting a marketing authorisation for Giapreza (angiotensin II), for the treatment of refractory hypotension in adults with septic or other distributive shock.
Two informed consent applications received a positive opinion from the CHMP: Azacitidine Celgene (azacitidine), for the treatment of myelodysplastic syndromes, chronic myelomonocytic leukaemia and acute myeloid leukemia; and Lacosamide UCB (lacosamide), for the treatment of partial-onset seizures with or without secondary generalisation. An informed consent application makes use of data from the dossier of a previously authorised medicine, with the marketing authorisation holder of that medicine giving consent for the use of their data in the application.
Negative opinion on a new medicine
The CHMP adopted a negative opinion recommending the refusal of a marketing authorisation for Evenity (romosozumab). Evenity was expected to be used to treat osteoporosis. For more information, please see the question-and-answer document in the grid below.
Start of re-examination of recommendation for new medicine
The applicant for Xyndari (glutamine) has requested a re-examination of the Committee's negative opinion for this medicine adopted at the May 2019 meeting. The CHMP will now re-examine the opinion and issue a final recommendation. For more information on this negative opinion, please see the question-and-answer document in the grid below.
New paediatric indication for type 2 diabetes medicine
The CHMP recommended an extension of indication for Victoza (liraglutide) to include the treatment of children and adolescents aged ten years or older with type 2 diabetes. For more information, please see the press release in the grid below.
Other extensions of indication recommended by the Committee were for Cyramza, Dupixent, Ebymect, Edistride, Fiasp, Flebogamma DIF, Forxiga, Imbruvica, Tecentriq, Xigduo and Zinforo.
Negative opinions on extension of therapeutic indication
The CHMP adopted a negative opinion for an extension of therapeutic indication for Revolade (eltrombopag) to add the treatment of previously untreated patients with severe aplastic anaemia from two years of age.
The Committee also adopted a negative opinion for an extension of the therapeutic indication of Translarna (ataluren) to add the treatment of patients with Duchenne muscular dystrophy who are no longer able to walk.
For more information on these negative opinions, please see the question-and-answer documents in the grid below.
Outcome of review on bacterial lysate medicines for respiratory conditions
The CHMP recommended that bacterial lysate medicines authorised for respiratory conditions should only be used for the prevention of recurrent respiratory infections, with the exception of pneumonia. This follows a review that concluded that there are no robust data showing that these medicines are effective at treating existing respiratory infections, or for the prevention of pneumonia, therefore they should not be used for these purposes. For more information, please see the public health recommendation in the grid below.
Withdrawal of application
The application for an initial marketing authorisation for ABP 710 (infliximab) was withdrawn. This medicine was intended for treatment of some inflammatory diseases. A question-and-answer document on this withdrawal is available in the grid below.
Agenda and minutes
The agenda of the June 2019 meeting is published on EMA's website. Minutes of the May 2019 CHMP meeting will be published in the coming weeks.
CHMP statistics
Key figures from the June 2019 CHMP meeting are represented in the graphic below.
Positive recommendation on new medicine
| Name of medicine | Giapreza |
| International non-proprietary name (INN) | angiotensin II |
| Marketing-authorisation applicant | La Jolla Pharmaceutical II B.V. |
| Therapeutic indication | Treatment of refractory hypotension in adults with septic or other distributive shock |
| More information | Giapreza: Pending EC decision |
Positive recommendations on new informed consent medicines
| Name of medicine | Azacitidine Celgene |
| INN | azacitidine |
| Marketing-authorisation applicant | Celgene Europe BV |
| Therapeutic indication | Treatment of myelodysplastic syndromes, chronic myelomonocytic leukaemia and acute myeloid leukemia |
| More information | Azacitidine Celgene: Pending EC decision |
| Name of medicine | Lacosamide UCB |
| INN | lacosamide |
| Marketing-authorisation applicant | UCB Pharma S.A. |
| Therapeutic indication | Treatment of partial-onset seizures with or without secondary generalisation |
| More information | Lacosamide UCB: Pending EC decision |
Negative recommendation on new medicine
| Name of medicine | Evenity |
| INN | romosozumab |
| Marketing-authorisation applicant | UCB Pharma S.A. |
| Therapeutic indication | Treatment of osteoporosis |
| More information | Evenity: Pending EC decision |
Start of re-examination of recommendation for new medicine
| Name of medicine | Xyndari |
| INN | glutamine |
| Marketing-authorisation applicant | Emmaus Medical Europe Ltd |
| Therapeutic indication | Treatment of sickle cell disease |
| More information | Xyndari: Pending EC decision |
Positive recommendations on extensions of indications
| Name of medicine | Cyramza |
| INN | ramucirumab |
| Marketing-authorisation holder | Eli Lilly Nederland B.V. |
| More information | Cyramza: Pending EC decision |
| Name of medicine | Dupixent |
| INN | dupilumab |
| Marketing-authorisation holder | sanofi-aventis groupe |
| More information | Dupixent: Pending EC decision |
| Name of medicine | Ebymect |
| INN | dapagliflozin / metformin |
| Marketing-authorisation holder | AstraZeneca AB |
| More information | Ebymect: Pending EC decision |
| Name of medicine | Edistride |
| INN | dapagliflozin |
| Marketing-authorisation holder | AstraZeneca AB |
| More information | Edistride: Pending EC decision |
| Name of medicine | Fiasp |
| INN | insulin aspart |
| Marketing-authorisation holder | Novo Nordisk A/S |
| More information | Fiasp: Pending EC decision |
| Name of medicine | Flebogamma DIF |
| INN | human normal immunoglobulin |
| Marketing-authorisation holder | Instituto Grifols, S.A. |
| More information | Flebogamma DIF (previously Flebogammadif): Pending EC decision |
| Name of medicine | Forxiga |
| INN | dapagliflozin |
| Marketing-authorisation holder | AstraZeneca AB |
| More information | Forxiga: Pending EC decision |
| Name of medicine | Imbruvica |
| INN | ibrutinib |
| Marketing-authorisation holder | Janssen-Cilag International NV |
| More information | Imbruvica: Pending EC decision |
| Name of medicine | Tecentriq |
| INN | atezolizumab |
| Marketing-authorisation holder | Roche Registration GmbH |
| More information | Tecentriq: Pending EC decision |
| Name of medicine | Victoza |
| INN | liraglutide |
| Marketing-authorisation holder | Novo Nordisk A/S |
| More information | Press release:New treatment for children with type 2 diabetes |
| Name of medicine | Xigduo |
| INN | dapagliflozin / metformin |
| Marketing-authorisation holder | AstraZeneca AB |
| More information | Xigduo: Pending EC decision |
| Name of medicine | Zinforo |
| INN | ceftaroline fosamil |
| Marketing-authorisation holder | Pfizer Ireland Pharmaceuticals |
| More information | Zinforo: Pending EC decision |
Negative recommendations on extension of indications
| Name of medicine | Revolade |
| INN | eltrombopag |
| Marketing-authorisation holder | Novartis Europharm Limited |
| More information | Revolade: Pending EC decision |
| Name of medicine | Translarna |
| INN | ataluren |
| Marketing-authorisation holder | PTC Therapeutics International Limited |
| More information | Translarna: Pending EC decision |
Public-health recommendation
| Name of medicine | Bacterial lysates-containing medicinal products indicated for respiratory conditions |
| INN | Haemophilus influenzae / Klebsiella pneumoniae / Moraxella catarrhalis / Staphylococcus aureus / Streptococcus mitis / S. pneumoniae / S. pyogenes, H. influenzae / K. pneumoniae / M. catarrhalis / Staphylococcus aureus / Streptococcus pneumoniae / S. pyogenes, S. pneumoniae / S. agalactiae / Staphylococcus aureus / H. influenzae, H. influenzae / K. ozaenae / K. pneumoniae / M. catarrhalis / Staphylococcus aureus / Streptococcus pneumoniae / S. pyogenes / S. viridans, H. influenzae / membrane fraction of K. pneumoniae / ribosomal fractions of K. pneumoniae / S. pneumoniae / S. pyogenes, Escherichia coli / K. pneumoniae / S. aureus / S. epidermidis / S. salivarius / S. pneumoniae / S. pyogenes / H. influenzae / Corynebacterium pseudodiphtheriticum / M. catarrhalis |
| More information | Bacterial lysate medicines for respiratory conditions to be used only for prevention of recurrent infections |
| Name of medicine | ABP 710 |
| INN | infliximab |
| Marketing-authorisation applicant | Amgen Europe B.V. |
| More information | ABP 710: Withdrawn application |
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