CHMP backs 13 treatments for EU approval

Thirteen new therapies - including two biosimilars - have been backed for approval in Europe.

Thirteen new medicines have been put forward for approval by the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP), covering a wide range of conditions such as cancer and chronic obstructive pulmonary disease.

Two cancer medicines were included in the latest batch of recommendations - Tesaro UK’s Zejula (niraparib), an orphan designated medicine intended for the treatment of ovarian cancer, and STEBA Biotech’s Tookad (padeliporfin), for the treatment of adenocarcinoma of the prostate.

If approved, Zejula would be the first oral, once-daily poly (ADP-ribose) polymerase (PARP) I/II inhibitor approved in Europe for use in patients regardless of BRCA mutation or biomarker status.

Two GlaxoSmithKline medicines targeting severe COPD in adult patients also won CHMP support - Elebrato Ellipta (fluticasone furoate/umeclidinium/vilanterol) and Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol).

MundiPharma’s nasal spray Nyxoid (naloxone), intended for the treatment of opioid overdose, and Orexo-partnered sublingual pill Zubsolv (buprenorphine/naloxone) for opioid dependence, were issued positive opinions following submission of hybrid applications - which rely in part on clinical evidence for a reference product and in part on new data.

Nyxoid could become the first intranasal formulation of naloxone to receive a pan-EU approval, offering a ‘first responders’ in overdose situations with "an easy to use, needle-free option that is suitable for use in a take-home naloxone setting," the firm noted.

Elsewhere, Janssen-Cilag’s Tremfya (guselkumab) was recommended for the treatment of plaque psoriasis, potentially offering patients the first treatment to selectively target interleukin (IL)-23 a key driver, of the immune inflammatory response in psoriasis, while Instituto Grifols’ VeraSeal (human fibrinogen/human thrombin) was backed for use as a sealant during surgical operations in adults.

Two biosimilar also made it through: Boehringer Ingelheim’s 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, marking the first trastuzumab biosimilar to be recommended for approval in Europe, Samsung Bioepis UK’s Ontruzant for the treatment of early and metastatic breast cancer and metastatic gastric cancer.

Finally, three generic medicines were issued a green light: Teva’s Imatinib Teva BV (imatinib) for the treatment of leukaemia and gastrointestinal stromal tumours; Gen.Orph’s Miglustat Gen.Orph (miglustat) for the treatment of mild to moderate type 1 Gaucher disease; and Mylan’s Ritonavir Mylan (ritonavir) for the treatment of HIV infection.