EMA’s human medicines committee (CHMP) recommended eight medicines for approval, including two orphan medicines, 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.

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.

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.

Zynquista (sotagliflozin), intended as an adjunct to insulin for certain patients with type 1 diabetes, received a positive opinion from the CHMP.

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.

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.

Other extensions of indication recommended by the Committee were for LynparzaRiarifyTrydonis 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.

Posted on the EMA website on 1 March 2019