Posted December 27, 2022 at 10:48 am
(Update: Context and Stock Price)
PARIS (Agefi-Dow Jones)–Pharmaceutical company Ipsen announced Friday evening that the Food and Drug Administration (FDA), the US health authority, has extended its review of its application for approval of palovarotene, for the treatment of patients with fibrodysplasia ossificans progressive (FOP).
Ipsen shares fell by 1.4% on the Paris Stock Exchange on Tuesday morning to 96.60 euros.
The FDA has issued a comprehensive response letter regarding palovarotene, following a previous request for more information communicated to Ipsen in October. The pharmaceutical group expects to respond to this new request in the first quarter of 2023 and expects a six-month review period from the FDA. “This is not a request for additional data on treatment efficacy and tolerability beyond the scope of existing studies,” the group said in a statement.
“The FDA has not yet announced a new date for a possible Endocrine and Metabolic Disease Treatments Advisory Committee meeting for the investigational drug palovarotene,” Ipsen added.
“While this request extends the review period for palovarotene’s application for approval, we continue to work with the FDA to provide the requested information and remain hopeful that investigational palovarotene can provide an innovative therapeutic solution,” said Howard Mayer, executive vice president by Ipsen, director of research and development, quoted in the same press release.
Authorization obtained in Canada and United Arab Emirates
Palovarotene was part of the portfolio of Canadian biotech company Clementia, acquired in 2019 by Ipsen for $1.04 billion. Since this transaction, Ipsen has fallen behind the development of palovarotene. Ipsen had also had to record a pre-tax depreciation of this asset of 669 million euros in its accounts for the financial year 2019.
In January 2022, the Canadian health authority, Health Canada, was the first regulatory authority to approve Sohonos, the trade name for palovarotene, to reduce heterotopic ossification in adults and children eight years of age and older for girls and ten years and older for boys with FOP. This treatment is also licensed in the UAE, while other authorities are currently reviewing it for approval.
FOP is an ultra-rare disease that causes continuous and permanent bone formation in soft and connective tissues, such as muscles, tendons and ligaments. As a result of abnormal bone formation during childhood and early adulthood, people living with FOP may permanently lose mobility in the neck, back, shoulders, chest, legs and limbs, arms and joints.
In the absence of disease-modifying treatments, palliative care remains the only treatment option. The average life expectancy is 56 years, with premature death caused by the formation of bone material around the rib cage causing respiratory problems and cardiorespiratory failure.
-Dimitri Delmond, Agefi-Dow Jones; +33(0)141274731; [email protected] ed: LBO
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December 27, 2022 at 04:48 AM ET (09:48 AM GMT)
