Europe recommends Entresto, fast-tracks Praxbind and Kyprolis

Europe’s key medicines committee has recommended 19 new medicines, with two fast-tracked under a rapid appraisal route.

The CHMP has recommended marketing authorisation (MA) with accelerated assessment for Boehringer Ingelheim’s Praxbind (idarucizumab), a specific antidote to Pradaxa (dabigatran etexilate), when rapid reversal of its anticoagulant effect is required.

Once approved, the drug will provide extra reassurance for healthcare professionals concerned about patients who experience ‘threatening or uncontrolled’ bleeding because of Pradaxa treatment.

The other drug reviewed under accelerated assessment was Amgen’s Kyprolis (carfilzomib) for multiple myeloma. It is now recommended for patients whose disease has relapsed after receiving at least one prior course of therapy. Kyprolis is for use in combination with lenalidomide and dexamethasone, and has an orphan designation.

Another major drug given the nod was Novartis’ new heart failure treatment Entresto (sacubitril/valsartan). It was recommended to treat symptomatic chronic heart failure with reduced ejection fraction – a condition where the heart muscle does not contract effectively and less oxygen-rich blood is pumped out to the body.

Amgen received more good news with the granting of a conditional MA for Blincyto (blinatumomab), which has an orphan designation. The drug is for Philadelphia chromosome-negative acute lymphoblastic leukaemia. Conditional MAs are one of the mechanisms put in place by the EMA to facilitate market access for medicines that fulfil unmet medical needs.

Other approvals

Roche’s Cotellic (cobimetinib) was recommended by the Committee for the treatment of metastatic melanoma.

Gilead’s single tablet Genvoya (elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide) received a positive opinion for HIV treatment.

GlaxoSmithKline’s Nucala (mepolizumab) was appoved for the treatment of asthma and Vertex’s Orkambi (lumacaftor/ivacaftor) for the treatment of cystic fibrosis.

Impax’s Numient (levodopa/carbidopa) received a positive opinion from the Committee for the treatment of Parkinson’s disease.

The Medicine Company’s Ionsys (fentanyl) was approved for the treatment of post-operative pain, and Sobi and Biogen’s Elocta (efmoroctocog alfa) was approved as an orphan drug for haemophilia A.

Another orphan drug, Horizon Pharma’s Ravicti (glycerol phenylbutyrate), received a positive opinion for the treatment of urea cycle disorders.

Two new approvals based on AstraZeneca’s diabetes drug Forixga were also recommended. Ebymect (dapagliflozin/metformin) and Edistride (dapagliflozin) received positive opinions for the treatment of type 2 diabetes. These medicines were submitted as informed consent applications, their approvals being based on previous Forxiga data dossiers.

Alimta generics approved

The CHMP also approved five generic medicines, including versions of Otsuka’s Abilify (aripiprazole) for the treatment of schizophrenia and the prevention and treatment of manic episodes of bipolar 1 disorder, and three versions of Lilly’s lung cancer chemotherapy treatment Alimta for unresectable malignant pleural mesothelioma and locally advanced or metastatic non-small cell lung cancer, and Amgen’s Sensipar (cinacalcet) for hyperparathyroidism and parathyroid carcinoma.

Finally, the CHMP also recommended extensions of indication for Eylea, Gilenya, Kalydeco, Opdivo, Rebetol and Vidaza.


CHMP meeting highlights

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