Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 19-22 March 2018

23 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.

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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.

CHMP statistics: March 2018

 

CHMP statistics: March 2018

Positive recommendations on new medicines

Name of medicine	Juluca
International non-proprietary name (INN)	dolutegravir / rilpivirine
Marketing-authorisation applicant	ViiV Healthcare UK Limited
Therapeutic indication	Treatment of HIV infection
More information	CHMP summary of positive opinion for Juluca

 

Name of medicine	Rubraca
INN	rucaparib
Marketing-authorisation applicant	Clovis Oncology UK Ltd
Therapeutic indication	Treatment of relapsed or progressive ovarian cancer
More information	CHMP summary of positive opinion for Rubraca

 

Positive recommendations on new generic medicines

Name of medicine	Pemetrexed Krka
INN	pemetrexed
Marketing-authorisation applicant	Krka d.d.
Therapeutic indication	Treatment of malignant pleural mesothelioma and non-small cell lung cancer
More information	CHMP summary of positive opinion for Pemetrexed Krka

 

Name of medicine	Prasugrel Mylan
INN	prasugrel
Marketing-authorisation applicant	Mylan S.A.S
Therapeutic indication	Prevention of atherothrombotic events
More information	CHMP summary of positive opinion for Prasugrel_Mylan

 

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	CHMP summary of positive opinion for Kanjinti

 

Name of medicine	Zessly
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	CHMP summary of positive opinion for Zessly

 

Negative recommendations for new medicines

Name of medicine	Dexxience
INN	betrixaban
Marketing-authorisation applicant	Portola Pharma UK Limited
Therapeutic indication	Prevention of venous thromboembolism
More information	Questions and answers on refusal of the marketing authorisation for Dexxience (betrixaban)

 

Name of medicine	Eladynos
INN	abaloparatide
Marketing-authorisation applicant	Radius International Ltd
Therapeutic indication	Treatment of osteoporosis
More information	Questions and answers on refusal of the marketing authorisation for Eladynos (abaloparatide)

 

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	Questions and answers on the positive opinion on the marketing authorisation for Nerlynx (neratinib)

 

Positive recommendations on extensions of indications

Name of medicine	Cabometyx
INN	cabozantinib
Marketing-authorisation holder	Ipsen Pharma
More information	CHMP post-authorisation summary of positive opinion for Cabometyx (II-03)

 

Name of medicine	Ivemend
INN	fosaprepitant
Marketing-authorisation holder	Merck Sharp & Dohme Limited
More information	CHMP post-authorisation summary of positive opinion for Ivemend

 

Name of medicine	Repatha
INN	evolocumab
Marketing-authorisation holder	Amgen Europe B.V.
More information	CHMP post-authorisation summary of positive opinion for Repatha II-17-G

 

Start of re-examination of recommendation on extension of indication

Name of medicine	Sutent
INN	sunitinib
Marketing-authorisation holder	Pfizer Limited
More information	Questions and answers on refusal of a change to the marketing authorisation for Sutent (sunitinib)

 

Start of referral

Name of medicine	Omega-3 fatty acid medicines
More information	EMA reviewing use of omega-3 fatty acid medicines after heart attacks

 

Public health recommendation

Name of medicine	Retinoid medicines
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	Questions and answers on the withdrawal of the application for a change to the marketing authorisation for Aranesp (darbepoetin alfa)

 

Other updates

Recommendations on eligibility to PRIME scheme - Adopted at the CHMP meeting of 19-22 March 2018

Scientific advice and protocol assistance adopted during the CHMP meeting 19 – 22 March 2018

Overview of (invented) names reviewed in February 2018 by the Name Review Group (NRG)