European News

European Commission gives orphan status to selinexor to treat myelofribrosis

Karyopharm Therapeutics and the Menarini Group’s Nexpovio (selinexor) has been granted orphan medicinal product designation by the European Commission (EC). The drug is intended to treat myelofibrosis (MF), a rare kind of bone marrow cancer.
MF interrupts the body’s normal production of blood cells, often leading to widespread bone marrow scarring, which consequently causes severe anaemia.
Nexpovio is currently being assessed for its treatment of MF patients, specifically those who have already been treated with existing therapies and have not reacted.
The drug was given orphan drug designation by the FDA in May 2022.
Karyopharm and the Menarini Group signed an exclusive licensing agreement in December 2021, meaning Menarini will oversee the commercialisation of Nexpovio across the UK, Switzerland, European Economic Area, CIS countries, Latin America and Turkey.
Reshma Rangwala, Karyopharm’s chief medical officer, said, “We are very pleased to receive orphan medicinal product designation from the EC for selinexor for the treatment of myelofibrosis. […] Building on our recent orphan drug designation from the FDA, this recognition continues to reinforce the significant unmet need for a drug with a novel mechanism of action like selinexor for this devastating disease. […] Our clinical plans remain on track, and we look forward to the continued development of selinexor in MF.”
Olivia del Puerto, MD LMS, head of medical affairs oncology at Menarini, added: “Myelofibrosis is a difficult-to-treat and complex disorder of the bone marrow with limited therapeutic options and we are committed to bringing novel treatments to patients through our collaboration with Karyopharm. We are excited about the potential to bring selinexor to myelofibrosis patients in Europe, pending positive study read-outs and regulatory approval.”