For Morphosys there is the next good news from the guselkumab project, in which the Munich-based company Janssen Research & Development has brought on board as a license partner. A positive opinion was received from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) on the extension of the approval of guselkumab – trade name Tremfya – for the treatment of adult patients with active psoriatic arthritis in the European Union.
Tremfya is currently approved in the EU for the treatment of moderate to severe plaque psoriasis (psoriasis) in adults. Whether the indication area is expanded as recommended by the CHMP is now up to the EU Commission, which, however, usually follows the expert recommendation. Morphosys expects a decision from Brussels this year.
“Because of its irreversibility and chronic course, active psoriatic arthritis is a major burden for patients and their families,” says Malte Peters, Chief Research and Development Officer at MorphoSys. “We are very pleased that Tremfya (R) has been recommended by the CHMP for extended approval. This opens up new treatment options that improve the lives of patients in the EU, ”said the manager.
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At a glance – chart and news: MorphoSys