Ipsen Receives FDA Approval for its Drug Against Bone Disease

Ipsen has received US Food and Drug Administration (FDA) approval for its drug against a rare bone disease. The biopharmaceutical company focused on innovation and specialized care received approval after the denial of its application by the European Medicines Agency (EMA).

The medicine is intended for adult and pediatric patients from the age of eight who have fibrodysplasia ossificans progressiva (FOP). Palovarotene becomes the first drug to treat this rare disease that until now had no therapy. Around the world, over a thousand people suffer from this rare anomaly.

Ipsen has already obtained approval in Canada and the United Arab Emirates. The biopharmaceutical company shelled out $1 billion in buying Clementia Pharmaceuticals to obtain the rights to palovarotene in 2019.

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Ipsen submitted the application for this drug to the EMA but it was rejected

Ipsen’s head of research and development, Howard Mayer, explains that “for the first time, clinicians have at their disposal an approved drug that has been shown to reduce the formation of new and abnormal bone growth, known as heterotopic ossification (HO), which it causes debilitating mobility problems and has a devastating impact on people’s lives.”

With this approval, the FDA also issued Ipsen a rare pediatric disease priority review voucher. This voucher can be used for subsequent drug requests that would not qualify for priority review.

Ipsen markets more than twenty medicines in more than 115 countries and has a direct commercial presence in more than 30 states. Ipsen’s research and development (R&D) is focused on its technology platforms located in the main biotechnology centers and cities of reference in life sciences: Paris-Saclay (France), Oxford (United Kingdom), and Cambridge (United States). ).

The group has 5,800 employees worldwide. Ipsen is listed on the Paris Stock Exchange. The Spanish subsidiary is located in L’Hospitalet de Llobregat (Barcelona). In Spain, the company has a portfolio with products in oncology (kidney, prostate, liver, thyroid, and neuroendocrine tumors), rare diseases (acromegaly, thyrotropic adenoma, fibrodysplasia ossificans progressiva (FOP), Turner syndrome and growth disorders) and neurosciences (movement disorders).

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(Featured image by jarmoluk via Pixabay)

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First published in PlantaDoce. A third-party contributor translated and adapted the article from the original. In case of discrepancy, the original will prevail.

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