Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 25-28 February 2019

News 01/03/2019

EMA’s human medicines committee (CHMP) recommended eight medicines for approval, including two orphan medicines1, at its February 2019 meeting. For three of the eight new medicines the CHMP recommended a conditional marketing authorisation.

This was the last meeting of the CHMP in London. As of March 2019, all meetings will take place at the new EMA headquarters in Amsterdam.

The Committee recommended granting a conditional marketing authorisation for Ondexxya (andexanet alfa). This medicine is to be used as an antidote for adult patients taking the anticoagulant medicines apixaban or rivaroxaban, when reversal of their action is needed due to life-threatening or uncontrolled bleeding. For more information, please see the press release in the grid below.

The Committee adopted a positive opinion for Palynziq (pegvaliase), a new medicine for patients aged 16 and older with phenylketonuria, a rare but potentially serious inherited metabolic disease. Palynziq was designated as an orphan medicine during its development. For more information, please see the press release in the grid below.

The CHMP recommended granting a conditional marketing authorisation for Waylivra (volanesorsen), the first medicine for the treatment of familial chylomicronaemia syndrome, a rare genetic disease that prevents the body from breaking down fats. Waylivra was designated as an orphan medicine during its development. For more information, please see the press release in the grid below.

Zynquista (sotagliflozin), intended as an adjunct to insulin for certain patients with type 1 diabetes, received a positive opinion from the CHMP. For more information, please see the press release in the grid below.

The Committee recommended granting a marketing authorisation under exceptional circumstances for Dectova (zanamivir), for the treatment of complicated and potentially life-threatening influenza.

The CHMP adopted a positive opinion, recommending the granting of a conditional marketing authorisation for Lorviqua (lorlatinib), for the treatment of patients with anaplastic lymphoma kinase-positive advanced non-small cell lung cancer.

Skyrizi (risankizumab) received a positive opinion for the treatment of moderate to severe psoriasis.

The Committee recommended for approval the generic medicine Pazenir (paclitaxel), for the treatment of metastatic breast cancer and non-small cell lung cancer.

Start of re-examination of recommendation for new medicine

The applicant for Doxolipad (doxorubicin) has requested a re-examination of the Committee's negative opinion for this medicine adopted at the January 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.

Five recommendations on extensions of therapeutic indication

The CHMP recommended an extension of indication of Dupixent as an add-on maintenance treatment for patients 12 years and older with certain forms of severe asthma. For more information, please see the press release in the grid below.

Other extensions of indication recommended by the Committee were for Lynparza, Riarify, Trydonis and Viread.

Withdrawals of application

The application for an initial marketing authorisation for Epjevy (pacritinib citrate) was withdrawn. This medicine was intended to be used to treat symptoms of myelofibrosis in patients with severe thrombocytopenia.

A question-and-answer document on this withdrawal is available in the grid below.

Agenda and minutes

The agenda of the February 2019 meeting is published on EMA's website. Minutes of the January 2019 CHMP meeting will be published in the coming weeks.

CHMP statistics

Key figures from the February 2019 CHMP meeting are represented in the graphic below.

 

1As always at time of approval, these orphan designations will now be reviewed by EMA's Committee for Orphan Medicinal Products (COMP) to determine whether the information available to date allows maintaining the medicines' orphan status and granting the medicines ten years of market exclusivity.

CHMP February 2019 figures

Positive recommendations on new medicines

Name of medicineDectova
International non-proprietary name (INN)zanamivir
Marketing-authorisation applicantGlaxoSmithKline Trading Services Limited
Therapeutic indication

Treatment of complicated and potentially life-threatening influenza.

Name of medicineLorviqua
INNlorlatinib
Marketing-authorisation applicantPfizer Europe MA EEIG
Therapeutic indication

Treatment of patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC).

Name of medicineOndexxya
INNandexanet alfa 
Marketing-authorisation applicantPortola Netherlands B.V. 
Therapeutic indication

Treatment of direct factor Xa(FXa) inhibitor (apixaban or rivaroxaban) when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding.

More informationFirst antidote for reversal of anticoagulation with factor Xa inhibitors apixaban and rivaroxaban
Name of medicinePalynziq
INNpegvaliase
Marketing-authorisation applicantBioMarin International Limited
Therapeutic indication

Treatment of phenylketonuria.

More informationCHMP recommends authorisation of new treatment for phenylketonuria, a rare inherited metabolic disease
Name of medicineSkyrizi
INNrisankizumab
Marketing-authorisation applicantAbbVie Deutschland GmbH & Co. KG
Therapeutic indication

Treatment of moderate to severe psoriasis.

Name of medicineWaylivra
INNvolanesorsen
Marketing-authorisation applicantAkcea Therapeutics Ireland Ltd
Therapeutic indication

Treatment of familial chylomicronaemia syndrome.

More informationFirst treatment for rare disease characterised by high levels of triglycerides in blood
Name of medicineZynquista
INNsotagliflozin
Marketing-authorisation applicantsanofi-aventis groupe
Therapeutic indication

Treatment of type 1 diabetes mellitus as an adjunct to insulin.

More informationNew add-on treatment to insulin for treatment of certain patients with type 1 diabetes

Positive recommendation on new generic medicine

Name of medicinePazenir (previously known as Paclitaxel Teva Pharma)
INNpaclitaxel
Marketing-authorisation applicantTeva B.V.
Therapeutic indication

Treatment of metastatic breast cancer and non-small cell lung cancer.

Start of re-examination of recommendation for new medicine

Name of medicineDoxolipad
INNdoxorubicin
Marketing-authorisation applicantTLC Biopharmaceuticals B.V.
Therapeutic indication

Treatment of breast and ovarian cancer.

Positive recommendations on extensions of indications

Name of medicineDupixent
INNdupilumab
Marketing-authorisation holder

sanofi-aventis groupe

More informationNew add-on treatment for patients with severe asthma
Name of medicineLynparza
INNolaparib
Marketing-authorisation holder

AstraZeneca AB

Name of medicineRiarify
INNbeclometasone dipropionate / formoterol fumarate dihydrate / glycopyrronium
Marketing-authorisation holder

Chiesi Farmaceutici S.p.A.

Name of medicineTrydonis
INNbeclometasone dipropionate / formoterol fumarate dihydrate / glycopyrronium
Marketing-authorisation holder

Chiesi Farmaceutici S.p.A.

Name of medicineViread
INNtenofovir disoproxil
Marketing-authorisation holder

Gilead Sciences Ireland UC

Outcome of arbitration procedure

Name of medicineSyner-KINASE 10 000 IU
More informationSyner-Kinase and associated names

Withdrawal of initial marketing authorisation application

Name of medicineEpjevy
INNpacritinib citrate
Marketing-authorisation applicantCTI Life Sciences Limited
More informationEpjevy: Withdrawn application

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