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US 10,864,194 B2Granted
Methods for treating heterotopic ossification
AssigneeClementia Pharmaceuticals Inc.
InventorsClarissa Desjardins, Donna Roy Grogan, Jeffrey Neal Packman, Mark Harnett
Life of this patent
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Abstract
The invention features dosing regimens and pharmaceutical formulations for oral administration of palovarotene. The dosing regimens can reduce heterotopic ossification, reduce the number of flare-ups, and/or reduce the severity of flare-ups in subjects suffering from fibrodysplasia ossificans progressiva.
Claims30
A method of reducing heterotopic ossification in a subject with fibrodysplasia ossificans progressiva, said method comprising:
- (i) during a period when the subject is not experiencing any flare-up symptom orally administering daily to the subject an amount of 5±0.5 mg of palovarotene, or a pharmaceutically acceptable salt thereof, and (ii) during a period when the subject is experiencing at least one flare-up symptom orally administering to the subject an amount of 20±1.0 mg of palovarotene, or a pharmaceutically acceptable salt thereof, daily for a period of 20 to 40 days, and after the period of 20 to 40 days, and amount of 10±1.0 mg of palovarotene, or a pharmaceutically acceptable salt hereof, daily for a period of 14 to 112 days.
A method of reducing heterotopic ossification in a subject with fibrodysplasia ossificans progressiva, said method comprising:
- (i) during a period when the subject is not experiencing any flare-up symptom orally administering daily to the subject an amount of 5 mg of palovarotene, or a pharmaceutically acceptable salt thereof, and (ii) during a period when the subject is experiencing at least one flare-up symptom orally administering daily to the subject an amount of 20 mg of palovarotene, or a pharmaceutically acceptable salt thereof, for 28 days, and after the 28 days, orally administering daily to the subject an amount of 10 mg of palovarotene, or a pharmaceutically acceptable salt thereof, for at least 56 days.
Dependencies are inferred from the claim text.