Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 24-27 June 2019

News 28/06/2019

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.

CHMP statistics: June 2019

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

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

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

Positive recommendations on extensions of indications

Name of medicine Cyramza
INN ramucirumab
Marketing-authorisation holder Eli Lilly Nederland B.V.
More information Cyramza

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

Name of medicine Edistride
INN dapagliflozin
Marketing-authorisation holder AstraZeneca AB
More information Edistride

Name of medicine Fiasp
INN insulin aspart
Marketing-authorisation holder Novo Nordisk A/S
More information Fiasp

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

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

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

Withdrawal of initial marketing authorisation application

Name of medicine ABP 710
INN infliximab
Marketing-authorisation applicant Amgen Europe B.V.
More information ABP 710: Withdrawn application

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