Novartis AG and Incyte Corp. said Friday that European Union regulators are recommended that their blood disorder drug Jakavi be approved.
The Committee for Medicinal Products for Human Use recommended approval for Jakavi as a treatment for enlarged spleen in patients who have a blood disorder called myelofibrosis. Jakavi is a pill taken twice per day. The European Medicines Agency is not required to follow recommendations from the advisory panel, but it often does so.
Myelofibrosis causes anemia, fatigue, pain and swelling of the spleen. It causes abnormal blood cells to build up in bone marrow, forming thick scar tissue that slows the production of healthy blood cells. To make up for the shortage, other organs including the liver and the spleen begin producing blood cells. It is a rare condition: Novartis said the disease affects less than one in every 100,000 people in the European Union.
The Swiss drugmaker said studies show that median survival for myelofibrosis patients is about 5.7 years.
The recommendation triggers a $40 million payment to Incyte from Novartis. Incyte will get another $60 million if the drug is approved and pricing is confirmed is certain EU countries. The U.S. Food and Drug Administration approved the drug in November under the name Jakafi.
Shares of Incyte, which is based in Wilmington, Del., rose 11 cents to $18.99 in midday trading. U.S.-traded shares of Novartis picked up $1.02 to $56.49.