The European Medicines Agency (EMA) has accepted GlaxoSmithKline (GSK)’s regulatory submission seeking an additional indication for Trelegy Ellipta to treat asthma, along with Type II Variation (T2V) Zejula to treat a type of ovarian cancer.
In addition, GSK has partnered with a consortium of philanthropic, non-profit and private sector organisations to advance the development of novel ‘pan-TB’ drug regimens, designed for the treatment of tuberculosis (TB). The drug regimens are currently ready for phase 3 development.
Bill & Melinda Gates Foundation global health president Trevor Mundel said: “Current tools are insufficient for accelerating and sustaining global progress against TB. Innovative partnerships, such as the PAN-TB collaboration, are urgently needed to develop new drugs and treatment regimens that can address TB and advance progress towards achieving global elimination TB goals.”
Trelegy Ellipta was previously approved by EU for COPD
The company has filed an application with EMA for an additional indication for Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol or FF/UMEC/VI) as once-daily, single-inhaler triple therapy for asthma.
FF/UMEC/VI is a combination of three molecules, fluticasone furoate, a corticosteroid, umeclidinium, a long-acting muscarinic antagonist and vilanterol, a long-acting beta2-adrenergic agonist. The drug is intended to be taken in a single inhalation, once a day, using the company’s Ellipta dry powder inhaler.
The EU has approved FF/UMEC/VI under the brand name Trelegy Ellipta, in November 2017, for the long-term, once-daily maintenance treatment of patients with chronic obstructive pulmonary disease (COPD).
GSK’s regulatory submission for Trelegy Ellipta is based on the results from Phase 3 CAPTAIN clinical trial, which met its primary endpoint, showing significant improvement in lung function compared to the ICS/LABA, Relvar/Breo Ellipta.
Type II Variation (T2V) Zejula is an oral, once-daily PARP inhibitor
GSK said that the EMA has validated its application seeking approval for T2V Zejula (niraparib) as a first-line maintenance treatment for advanced ovarian cancer in women, who responded to platinum-based chemotherapy regardless of biomarker status.
EMA’s validation of the T2V Zejula is believed to be its acceptance of regulatory submission and is expected to start the review process, through the committee for human medicinal products (CHMP), said the company.
Niraparib is an oral, once-daily PARP inhibitor, currently being evaluated in multiple pivotal trials, which include several combination studies, including a Phase III study as a first-line triplet maintenance treatment in ovarian cancer (FIRST).
GSK’s regulatory submission for T2V Zejula is supported by the data from PRIMA study, which evaluated the effectiveness of niraparib, compared to placebo, for stage III or IV ovarian cancer in women.
The study enrolled women who responded to first-line treatment with platinum-based chemotherapy, including a population with a high risk of disease progression and previously under-represented in first-line ovarian cancer studies and showed clinically meaningful outcomes of niraparib.
