CHMP recommends several drugs for EU market approval

pharmafile | October 21, 2019 | News story | Sales and Marketing  

The EMA’s human medicines committee (CHMP) has recommended seven medicines for approval at its October 2019 meet including MSD’s Ervebo, AbbVie’s Rinvoq and Janssen’s major depressive disorder treatment Spravato.

The committee supported the first condition marketing authorisation for MSD’s Ervebo, for the active immunisation of adults at risk of infection with Ebola virus. The recommendation was given under the EMAs PRIME scheme on phase III data reviewed under the Agency’s accelerated programme because of the urgent medical need for a preventative vaccine for haemorrhagic fever caused by the virus.

The second drug receiving marketing authorisation was Eli Lilly’s Baqsimi, an intranasal glucagon for patients with severe hypoglycaemia aged four years and older. Severe hypoglycaemia is a serious acute complication of diabetes, which occurs when blood sugar levels fall to a level where the patient becomes confused or unconscious, requiring assistance from another person to administer the medication.

Quofenix (delafloxacin) also received a positive opinion from the CHMP for the treatment of acute bacterial skin and skin structure infections in adults when it is considered unfeasible to use other antibacterial agents.

Additionally, the committee recommended marketing authorisation for AbbVie’s FDA-approved Jak-1 inhibitor Rinvoq (upadactinib) in the treatment of rheumatoid arthritis.

Janssen’s Spravato (esketamine), an intranasal spray for treatment-resistant major depressive disorder in adults also received a positive opinion and additionally the biosimilar medication Pegfilgrastim from Mundipharma intended to reduce the duration of neutropenia as well as the incidence of febrile neutropenia due to chemotherapy too received positive opinions from the Committee.

Although initially in June this year the CHMP adopted a negative opinion for Evenity (romosozumab), a monoclonal antibody therapy commercialised by Amgen and UCB for the treatment of postmenopausal women with severe osteoporosis at high risk of fracture; after re-examination the CHMP changed its mind and granted a positive opinion for a restricted indication. There are also additional measures in place to ensure that the medicine is used correctly and in line with current guidance.

Nik Kiran

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