EMA accepts submissions for GSK's Zejula and Trelegy Ellipta

27 February 2020

UK pharma major GlaxoSmithKline (LSE: GSK) today announced that the European Medicines Agency has accepted submissions for two of its already-marketed drugs for approval of additional indications.

The EMA has validated the company's Type II Variation (T2V) for Zejula (niraparib) as a maintenance treatment in the first-line setting for women with advanced ovarian cancer who responded to platinum-based chemotherapy regardless of biomarker status. Validation of the T2V confirms that the submission is accepted and begins the formal review process by the EMA's Committee for Human Medicinal Products (CHMP).

The submission is based on data from the PRIMA study (ENGOT-OV26/GOG-3012), which demonstrated clinically meaningful outcomes of niraparib treatment in the first-line maintenance setting. Results from the PRIMA study were presented at the 2019 European Society for Medical Oncology Congress and simultaneously published in the New England Journal of Medicine.

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