Actelion has won EU approval for Ledaga, a drug to treat a rare form of lymphoma that manifests itself in the skin, but says it does not expect to launch it before January 2018.
The Swiss biotech – which already sells Ledaga (mechlorethamine or chlormethine) under the Valchlor brand in the US – notes that the European Commission cleared the drug as a topical treatment for mycosis fungoides-type cutaneous T-cell lymphoma (MF-CTCL) in patients who have received prior skin-directed therapy.
Actelion needs to meet a list of post-approval requirements from the EMA’s Committee for Medical Products for Human Use (CHMP) and says that fulfilling those commitments and securing reimbursement and other patient access approvals will push back a launch into next year.
MF-CTLC is the most common form of cutaneous T-cell lymphoma, typically seen in people aged over 50 and most commonly in men. If caught early the cancer is easy to treat, but unfortunately is often mistaken for eczema or psoriasis in its early stages, and around a third of patients go on to develop more advanced stages which can involve it spreading to the liver, spleen and lungs.
Ledaga’s approval is based is on the results of a 260-patient study in which 77% of patients who were treated for at least six months with chlormethine gel achieved a clinical response, compared to 59% of those treated with a matched control.
The green light is a minor boost to Actelion’s efforts to expand its specialty drugs business beyond its core portfolio of treatments for pulmonary artery hypertension, which still account for the lion’s share of its revenues, as it navigates through the process of being taken over by Johnson & Johnson (J&J) in a $30bn deal.
Valchlor was first launched in the US in 2013 and has grown fairly slowly, with sales reaching CHF35m ($34m) last year, up a third on 2015’s tally but still failing to meet expectations. Mechlorethamine has been used for years as an intravenous treatment for MF-CTCL, and Valchlor also has to compete with unapproved topical formulations of the drug produced by compounding pharmacies in the US.
Actelion acquired Valchlor in 2013 when it bought Ceptaris for $250m plus milestones.