Thirteen medicines recommended for approval, including one orphan medicine
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended thirteen medicines for approval at its September meeting.
The CHMP recommended granting marketing authorisations for two cancer medicines: Zejula (niraparib), an orphan designated medicine intended for the treatment of ovarian cancer, and Tookad (padeliporfin), for the treatment of adenocarcinoma of the prostate.
Two medicines for the treatment of adults with moderate to severe chronic obstructive pulmonary disease also received a positive opinion from the Committee: Elebrato Ellipta (fluticasone furoate / umeclidinium / vilanterol) and Trelegy Ellipta (fluticasone furoate / umeclidinium / vilanterol).
CHMP gave positive opinions for two medicines for people using opioids: Nyxoid(naloxone), intended for the treatment of opioid overdose, and Zubsolv (buprenorphine / naloxone), intended for the treatment of opioid dependence. Hybrid applications were submitted for both medicines. This means that the marketing authorisation applications relied in part on the results of pre-clinical tests and clinical trials for a reference product and in part on new data.
The CHMP adopted a positive opinion for Tremfya (guselkumab) for the treatment of plaque psoriasis.
VeraSeal (human fibrinogen / human thrombin) received a positive opinion for use as a sealant during surgical operations in adults.
Two biosimilar medicines were recommended for approval by the Committee: Cyltezo(adalimumab) for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, axial spondyloarthritis, psoriatic arthritis, psoriasis, paediatric plaque psoriasis, hidradenitis suppurativa, Crohn’s disease, ulcerative colitis and uveitis; and Ontruzant(trastuzumab) for the treatment of early and metastatic breast cancer, and metastatic gastric cancer. Ontruzant is the first trastuzumab biosimilar recommended for approval by the CHMP.
Three generic medicines received a positive opinion from the CHMP: Imatinib Teva B.V. (imatinib) for the treatment of leukaemia and gastrointestinal stromal tumours; Miglustat Gen.Orph (miglustat) for the treatment of mild to moderate type 1 Gaucher disease; and Ritonavir Mylan (ritonavir) for the treatment of HIV infection.
Outcome of re-examination of three negative recommendations
The applicants for Adlumiz (anamorelin hydrochloride), Human IgG1 monoclonal antibody specific for human interleukin-1 alpha XBiotech (human IgG1 monoclonal antibody specific for human interleukin-1 alpha) and Masipro (masitinib) requested re-examinations of the Committee’s negative opinions for these medicines adopted at the May 2017 meeting. After considering the grounds for these requests, the CHMP re-examined the initial opinions and confirmed its previous recommendations to refuse the granting of marketing authorisations for these medicines.
Four recommendations on extensions of therapeutic indications
The Committee recommended extensions of indications for Benlysta, Tasigna, Firazyr and Stribild.
Negative opinion on one extension of therapeutic indication
The CHMP adopted a negative opinion for an extension of therapeutic indication for Raxone.
Outcome of review on factor VIII
The CHMP concluded that there is no clear and consistent evidence of a difference in the incidence of inhibitor development between the two classes of factor VIII medicines: those derived from plasma and those made by recombinant DNA technology.
Withdrawals of applications
Applications for initial marketing authorisations for Fulphila (pegfilgrastim), Ogivri (trastuzumab) and Tigecycline Accord (tigecycline) have been withdrawn.
Fulphila was intended to be used for reducing neutropenia in patients taking cancer treatments. Ogivri was intended to be used to treat breast and gastric cancers. Tigecycline Accord was intended to be used to treat certain complicated infections.
An application to extend the indication of Opdivo (nivolumab) to treat liver cancer has also been withdrawn.