Seven medicines recommended for approval, including one orphan
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended seven medicines for approval, including one orphan medicine, at its January 2018 meeting.
The CHMP recommended granting a marketing authorisation for Hemlibra (emicizumab), a first-in-class medicine to prevent bleeding episodes in patients with haemophilia A who have factor VIII inhibitors. This medicine was reviewed under EMA’s accelerated assessment procedure, reserved for medicines of major public health interest.
The CHMP recommended granting a marketing authorisation for Lamzede (velmanase alfa), a long-term enzyme replacement therapy in adults, adolescents and children with mild to moderate forms of alpha-mannosidosis. Because alpha-mannosidosis is a very rare disease, Lamzede was granted an orphan designation.
The Committee recommended granting a marketing authorisation for Shingrix (recombinant, adjuvanted Herpes zoster vaccine), a vaccine for the prevention of herpes zoster and post-herpetic neuralgia in adults 50 years of age or older.
The CHMP gave positive opinions for three medicines to treat type 2 diabetes: Segluromet (ertugliflozin / metformin), Steglatro (ertugliflozin) and Steglujan (ertugliflozin / sitagliptin).
One biosimilar medicine was recommended for approval by the Committee: Semglee (insulin glargine), for the treatment of diabetes.
Re-adoption of opinion on new medicine
The CHMP confirmed its previous positive opinion and recommended the granting of a marketing authorisation for Lokelma (sodium zirconium cyclosilicate), for the treatment of hyperkalaemia.
Lokelma had received a positive opinion in February 2017. However, the European Commisson suspended its decision-making following some concerns relating to good manufacturing practices (GMP) at the manufacturing site for the active substance and referred the matter back to the CHMP. A new inspection of the manufacturing site for Lokelma’s active substance showed that the site is compliant with GMP. On the basis of the inspection findings, the Committee confirmed its previous opinion.
Negative opinion on new medicine
The CHMP adopted a negative opinion for EnCyzix (enclomifene). EnCyzix was expected to be used to treat hypogonadotrophic hypogonadism in men.
Start of re-examination of recommendation on new medicine
The applicant for Aplidin (plitidepsin) has requested a re-examination of the Committee’s negative opinion for this medicine adopted at the December 2017 meeting. The CHMP will now re-examine this opinion and issue a final recommendation.
Three recommendations on extensions of therapeutic indication
The Committee recommended extensions of indications for Hizentra, Relvar Ellipta and Revinty Ellipta.
Negative recommendation on extension of indication following re-examination
The applicant for Raxone (idebenone) requested a re-examination of the Committee’s negative opinion for this medicine adopted at the September 2017 meeting. After considering the grounds for this request, the CHMP re-examined the opinion, and confirmed the refusal of the change to the marketing authorisation.
Withdrawals of applications
Applications for initial marketing authorisations for Balimek (binimetinib) and Rotigotine Mylan (rotigotine) have been withdrawn. Balimek was intended to be used to treat melanoma (a type of skin cancer) that had spread or could not be removed by surgery. Rotigotine Mylan was intended to be used to treat Parkinson’s disease and restless-leg syndrome.
An application to extend the use of Opdivo (nivolumab) to treat colorectal cancer has also been withdrawn.