Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 19-22 March 2018
Six medicines recommended for approval, including one orphan
The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended six medicines for approval, including one orphan medicine1, at its March 2018 meeting.
The CHMP recommended granting a conditional marketing authorisation for Rubraca (rucaparib), for the treatment of relapsed or progressive ovarian cancer. Rubraca was designated as an orphan medicine during its development.
Juluca (dolutegravir / rilpivirine) received a positive opinion for the treatment of human immunodeficiency virus (HIV) infection.
Two biosimilar medicines were recommended for approval by the Committee: Kanjinti (trastuzumab) for the treatment of breast and gastric cancer; and Zessly (infliximab) for the treatment of rheumatoid arthritis, Crohn's disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and psoriasis.
Two generic medicines received a positive opinion from the CHMP: Pemetrexed Krka (pemetrexed), for the treatment of malignant pleural mesothelioma and non-small cell lung cancer; and Prasugrel Mylan (prasugrel), for the prevention of atherothrombotic events.
Negative opinions on two new medicines
The CHMP adopted a negative opinion for Dexxience (betrixaban). Dexxience was expected to be used for the prevention of venous thromboembolism.
The Committee also adopted a negative opinion for Eladynos (abaloparatide). Eladynos was intended to be used to treat osteoporosis.
For more information on these negative opinions, please see the question-and-answer documents in the grid below.
Negative recommendation on new medicine following re-examination
The CHMP confirmed its previous recommendation to refuse the granting of a marketing authorisation for Aplidin (plitidepsin). Aplidin was expected to be used to treat adults with multiple myeloma. This followed a request from the applicant for the re-examination of the Committee's negative opinion for the medicine adopted at the December 2017 meeting.
For more information on this negative opinion, please see the question-and-answer document in the grid below.
Start of re-examination of recommendation on new medicine
The applicant for Nerlynx (neratinib) has requested a re-examination of the Committee's negative opinion for this medicine adopted at the February 2018 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.
Three recommendations on extensions of therapeutic indication
The Committee recommended extensions of indications for Cabometyx, Ivemend and Repatha.
Start of re-examination of recommendation on extension of therapeutic indication
The applicant for Sutent (sunitinib) has requested a re-examination of the Committee's negative opinion for this medicine adopted at the February 2018 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.
Start of referral: omega-3 fatty acid medicines
The CHMP started a review of the use of omega-3 fatty acid medicines in patients who have had a heart attack, following research showing that these oral products may not prevent recurrence of heart disease or stroke. For more information, please see the start-of-referral document in the grid below.
Outcome of review on retinoid medicines
The CHMP concluded its review of retinoid medicines, and confirmed that retinoids can harm the unborn child and must not be used during pregnancy. In addition, a warning on the possibility that neuropsychiatric disorders (such as depression, anxiety and mood changes) may occur will be included in the prescribing information for oral retinoids. For more information, please see the public health recommendation in the grid below.
Withdrawal of application
An application to extend the indication of Aranesp (darbepoetin alfa) to treat anaemia in patients with myelodysplastic syndromes has been withdrawn. A question-and-answer document on this withdrawal is available in the grid below.
Agenda and minutes
The agenda of the March 2018 meeting is published on EMA's website. Minutes of the February 2018 CHMP meeting will be published in the coming weeks.
CHMP statistics
Key figures from the March 2018 CHMP meeting are represented in the graphic below.
More information on all other outcomes of the CHMP March 2018 meeting is available in the grid below.
1As always at time of approval, this orphan designation will now be reviewed by EMA's Committee for Orphan Medicinal Products (COMP) 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 | Juluca |
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International non-proprietary name (INN) | dolutegravir / rilpivirine |
Marketing-authorisation applicant | ViiV Healthcare UK Limited |
Therapeutic indication | Treatment of HIV infection |
More information |
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Name of medicine | Rubraca |
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INN | rucaparib |
Marketing-authorisation applicant | Clovis Oncology UK Ltd |
Therapeutic indication | Treatment of relapsed or progressive ovarian cancer |
More information |
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Positive recommendations on new generic medicines
Name of medicine | Pemetrexed Krka |
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INN | pemetrexed |
Marketing-authorisation applicant | Krka d.d. |
Therapeutic indication | Treatment of malignant pleural mesothelioma and non-small cell lung cancer |
More information |
|
Name of medicine | Prasugrel Mylan |
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INN | prasugrel |
Marketing-authorisation applicant | Mylan S.A.S |
Therapeutic indication | Prevention of atherothrombotic events |
More information |
|
Positive recommendations on new biosimilar medicines
Name of medicine | Kanjinti |
---|---|
INN | trastuzumab |
Marketing-authorisation applicant | Amgen Europe B.V., BREDA |
Therapeutic indication | Treatment of breast and gastric cancer |
More information |
|
Name of medicine | Zessly |
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INN | infliximab |
Marketing-authorisation applicant | Sandoz GmbH |
Therapeutic indication | Treatment of rheumatoid arthritis, Crohn's disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and psoriasis |
More information |
|
Negative recommendations for new medicines
Name of medicine | Dexxience |
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INN | betrixaban |
Marketing-authorisation applicant | Portola Pharma UK Limited |
Therapeutic indication | Prevention of venous thromboembolism |
More information |
|
Name of medicine | Eladynos |
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INN | abaloparatide |
Marketing-authorisation applicant | Radius International Ltd |
Therapeutic indication | Treatment of osteoporosis |
More information |
|
Negative recommendation for new medicine following re-examination
Name of medicine | Aplidin |
---|---|
INN | plitidepsin |
Marketing-authorisation applicant | Pharma Mar |
Therapeutic indication | Treatment of multiple myeloma |
More information |
Start of re-examination of recommendation for new medicine
Name of medicine | Nerlynx |
---|---|
INN | neratinib |
Marketing-authorisation applicant | Puma Biotechnology Limited |
Therapeutic indication | Treatment of breast cancer |
More information |
|
Positive recommendations on extensions of indications
Name of medicine | Cabometyx |
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INN | cabozantinib |
Marketing-authorisation holder | Ipsen Pharma |
More information |
|
Name of medicine | Ivemend |
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INN | fosaprepitant |
Marketing-authorisation holder | Merck Sharp & Dohme Limited |
More information |
|
Name of medicine | Repatha |
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INN | evolocumab |
Marketing-authorisation holder | Amgen Europe B.V. |
More information |
|
Start of re-examination of recommendation on extension of indication
Name of medicine | Sutent |
---|---|
INN | sunitinib |
Marketing-authorisation holder | Pfizer Limited |
More information |
|
Start of referral
Name of medicine | Omega-3 fatty acid medicines |
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More information | EMA reviewing use of omega-3 fatty acid medicines after heart attacks |
Public health recommendation
Name of medicine | Retinoid medicines |
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More information | Updated measures for pregnancy prevention during retinoid use |
Medication error
Name of medicine | Fiasp |
---|---|
INN | insulin aspart |
Marketing-authorisation holder | Novo Nordisk A/S |
More information | Colour change for insulin injection Fiasp to avoid mix ups with Tresiba |
Withdrawal of application for extension of indication
Name of medicine | Aranesp |
---|---|
INN | darbepoetin alfa |
Marketing-authorisation applicant | Amgen Europe B.V. |
More information |
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Other updates
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Related content
- Aplidin: EPAR
- Aranesp: EPAR
- Cabometyx : EPAR
- Dexxience: EPAR
- Eladynos: EPAR
- Fiasp: EPAR
- Ivemend: EPAR
- Juluca: EPAR
- Kanjinti: EPAR
- Nerlynx: EPAR
- Pemetrexed Krka: EPAR
- Prasugrel Mylan: EPAR
- Repatha: EPAR
- Rubraca: EPAR
- Sutent: EPAR
- Zessly: EPAR
- Omega-3 acid ethyl esters - containing medicinal products for oral in use in secondary prevention after myocardial infarction: Article 31 referrals
- Retinoid-containing medicinal products: Article 31 referrals