EMA’s human medicines committee (CHMP) September meeting highlights

In its latest meeting, the European Medicine Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) recommended nine new medicines and concluded its analysis on the risk of thrombosis with thrombocytopenia syndrome (TTS) with Vaxzevria.

Recommendations of approval

The committee adopted a positive opinion for Artesunate Amivas (artesunate), for the initial treatment of severe malaria in adults and children. This medicine has an orphan designation because malaria has a low prevalence in the EU.

The CHMP recommended granting a marketing authorisation for Brukinsa (zanubrutinib), for the treatment of Waldenström’s macroglobulinaemia.

The committee adopted a positive opinion, recommending the granting of a conditional marketing authorisation for Gavreto (pralsetinib) for the treatment of non-small cell lung cancer (NSCLC).

The CHMP also recommended granting a marketing authorisation for Qinlock (ripretinib) for the treatment of advanced gastrointestinal stromal tumour (GIST).

Vumerity (diroximel fumarate) was granted a positive opinion for the treatment of adult patients with relapsing remitting multiple sclerosis.

Two biosimilar medicines were recommended for approval by the committee: Hukyndra and Libmyris (both containing adalimumab) for the treatment of inflammatory auto-immune disorders.

Additionally, two generic medicines received a positive opinion from the CHMP: Sugammadex Mylan (sugammadex) intended for the reversal of induced neuromuscular blockade and Rivaroxaban Mylan (rivaroxaban), an anti-coagulant intended for the prevention and treatment of atherothrombotic and venous thromboembolic events in certain at-risk patients.

Negative opinion on Raylumis

The CHMP recommended the refusal of a marketing authorisation for Raylumis (tanezumab), intended for the treatment of pain associated with osteoarthritis.

CHMP recommendations on extensions of therapeutic indication for nine medicines

The committee recommended granting three extensions of indication for Nucala (mepolizumab), including the extension for the treatment of eosinophilic granulomatosis with polyangiitis.

Other extensions of indication recommended by the committee were for Firmagon, Jyseleca, Keytruda, Noxafil, Opdivo, Segluromet, Steglatro and Zepatier.

CHMP conclusion of Article 5(3) review on Vaxzevria

The committee has concluded its further analysis of data on the risk of unusual blood clots linked to thrombosis with thrombocytopenia syndrome (TTS) and on the use of a second dose of Vaxzevria, reinforcing its interim opinion of April 2021.

A scientific opinion was requested by the European Commission (EC) following the initial reports of TTS associated with the vaccine. EMA analysed all the available data, including the latest TTS data from spontaneous reports in EudraVigilence, detailed vaccination data from EU Member States and an additional commissioned study of the risk of blood clots that was reviewed in detail by EMA’s safety committee (PRAC).

The evidence did not allow EMA to identify particular risk factors that make TTS more likely. Although spontaneous reports when put in relation to the exposure have suggested that the risk may be higher in women and in younger adults, and lower after the second compared to the first dose, the limitations of the way the data is collected mean that none of these differences could be confirmed.

EMA’s recommendation remains to continue giving a second dose of Vaxzevria between four and 12 weeks after the first, in line with the product information. There is no evidence that delaying the second dose has any influence on the risk of TTS. 

Withdrawal of applications

Applications for an initial marketing authorisation for four medicines were withdrawn: 

• Livmarli (maralixibat) for the treatment of progressive familial intrahepatic cholestasis type 2 (PFIC2) in patients one year of age and older
• Oportuzumab monatox DLRC Pharma Services (oportuzumab monatox) for the treatment and prevention of recurrence of cancer of the bladder and the prevention of recurrence of papillary tumours
• Sildenafil FGK (sildenafil) for the treatment of erectile dysfunction in adult men
• Teriparatide Cinnagen (teriparatide) for the treatment osteoporosis.

CHMP concludes assessment of presence of a nitrosamine impurity in Champix

The committee concluded its analysis on the presence of impurity N-nitroso-varenicline in Champix at levels above those considered acceptable for EU medicines. As part of the assessment, the committee considered the criticality of Champix in the context of its current therapeutic use and the availability of alternative treatment options. The CHMP concluded that higher impurity limits were not acceptable as the product was not critical and its absence from the EU market would not create a concern in terms of public health. The CHMP stated that patients should not stop taking Champix without first consulting their healthcare professional and talk to them if they have any questions or concerns.