European Commission Grants Orphan Medicinal Product Designation to Karyopharm and Menarini Group


The European Commission has granted Orphan Medicinal Product Designation to Karyopharm Therapeutics Inc., a pharmaceutical company pioneering cancer therapies, and Menarini Group, a leading international pharmaceutical company, for selinexor used to treat myelofibrosis (MF).

Selinexor was granted the orphan drug designation by the US Food and Drug Administration (FDA) in May 2022. Selinexor is currently being evaluated by Karyopharm Therapeutics Inc., as monotherapy in patients with previously treated myelofibrosis, in combination with ruxolitinib.

Karyopharm chief medical officer, Reshma Rangwala, said that they are pleased to receive orphan medicinal product designation from the European Commission for selinexor to treat patients with myelofibrosis.

Reshma Rangwala added that, building on their recent orphan drug designation from the US FDA, this recognition from the European Commission continues to reinforce the significant unmet need for a drug with a novel mechanism of action such as selinexor for the dangerous disease.

Olivia del Puerto, head of medical affairs oncology, at EMEA for Menarini, said that MF is a complex disorder of the bone marrow with limited therapeutic options, and they are committed to bringing novel treatments to patients through their partnership with Karyopharm. They are very excited to bring selinexor to MF patients in Europe.  

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