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FDA approves first treatment for Fibrodysplasia Ossificans Progressiva
(Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - August 17, 2023 Category: Drugs & Pharmacology Authors: FDA Source Type: news

First Therapy Approved for Ultra-Rare Bone Disorder
(MedPage Today) -- The FDA approved the oral retinoid palovarotene (Sohonos) for treating abnormal bone growth associated with fibrodysplasia ossificans progressiva (FOP), drugmaker Ipsen announced on Wednesday. Palovarotene, a selective retinoic... (Source: MedPage Today Public Health)
Source: MedPage Today Public Health - August 16, 2023 Category: American Health Source Type: news

EU Marketing Authorization Rejected for Bone Disorder Drug EU Marketing Authorization Rejected for Bone Disorder Drug
French drugmaker Ipsen said on Wednesday the European Commission has not granted marketing authorization for palovarotene, an investigational treatment for fibrodysplasia ossificans progressiva.Reuters Health Information (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - July 20, 2023 Category: Consumer Health News Tags: Diabetes & Endocrinology News Source Type: news

FDA Panel Backs Palovarotene for Ultra-Rare Bone Disorder
(MedPage Today) -- Despite lingering concerns over post hoc analyses, palovarotene won the support of an FDA panel as a treatment for abnormal bone growth due to fibrodysplasia ossificans progressiva (FOP). By a vote of 10-4, members of the Endocrinologic... (Source: MedPage Today Public Health)
Source: MedPage Today Public Health - June 29, 2023 Category: American Health Source Type: news

FDA Staff Weighs 'Alternative' Data on Retinoid for Rare Bone Disorder
(MedPage Today) -- Credit: Joh-co Study design, problematic statistical analyses, and risk management appeared to blunt the enthusiasm of FDA staff reviewing the investigational agent palovarotene for fibrodysplasia ossificans progressiva... (Source: MedPage Today Public Health)
Source: MedPage Today Public Health - June 27, 2023 Category: American Health Source Type: news

Ipsen Receives Complete Response Letter for Palovarotene, an Investigational Treatment for Fibrodysplasia Ossificans Progressiva
The CRL is related to the U.S. FDA’s previous request for additional information on palovarotene clinical trial data Ipsen anticipates responding to the request in the first quarter of 2023 PARIS, FRANCE, 23 December 2022– The... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - December 23, 2022 Category: Drugs & Pharmacology Source Type: news

Ipsen Announces U.S. FDA Priority Review for Palovarotene New Drug Application in Patients With Fibrodysplasia Ossificans Progressiva Following Resubmission
PARIS--(BUSINESS WIRE)--Regulatory News: June 29, 2022 -- Ipsen (Euronext: IPN; ADR: IPSEY) today announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review its resubmitted New Drug Application (NDA) for... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - June 29, 2022 Category: Drugs & Pharmacology Source Type: news

Ipsen Confirms U.S. FDA Accepts New Drug Application for Palovarotene as the First Potential Treatment Worldwide for Fibrodysplasia Ossificans Progressiva (FOP)
PARIS, FRANCE, 28 May 2021– Ipsen (Euronext: IPN; ADR: IPSEY) today announced that its New Drug Application (NDA) for palovarotene, an oral, investigational, selective RARγ agonist for the prevention of heterotopic ossification... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - May 28, 2021 Category: Drugs & Pharmacology Source Type: news

Augmented BMP signaling commits cranial neural crest cells to a chondrogenic fate by suppressing autophagic {beta}-catenin degradation
Cranial neural crest cells (CNCCs) are a population of multipotent stem cells that give rise to craniofacial bone and cartilage during development. Bone morphogenetic protein (BMP) signaling and autophagy have been individually implicated in stem cell homeostasis. Mutations that cause constitutive activation of the BMP type I receptor ACVR1 cause the congenital disorder fibrodysplasia ossificans progressiva (FOP), which is characterized by ectopic cartilage and bone in connective tissues in the trunk and sometimes includes ectopic craniofacial bones. Here, we showed that enhanced BMP signaling through the constitutively ac...
Source: Signal Transduction Knowledge Environment - January 12, 2021 Category: Science Authors: Yang, J., Kitami, M., Pan, H., Nakamura, M. T., Zhang, H., Liu, F., Zhu, L., Komatsu, Y., Mishina, Y. Tags: STKE Research Articles Source Type: news

Woman, 35, is 'turning into a statue' due to a one-in-a-million condition
Rachel Winnard, 35, of Rochdale, Greater Manchester, suffers from the genetic disorder Fibrodysplasia Ossificans Progressiva, which causes bony bars to form within the body's muscles. (Source: the Mail online | Health)
Source: the Mail online | Health - August 7, 2019 Category: Consumer Health News Source Type: news

The woman who is slowly 'turning to STONE': Condition causes muscle to gradually change into bone
Carli Henrotay, of Saint Louis, Missouri, has the genetic condition fibrodysplasia ossificans progressiva. With a life expectancy of 40, it gets progressively worse with age and has no cure. (Source: the Mail online | Health)
Source: the Mail online | Health - May 28, 2019 Category: Consumer Health News Source Type: news

Hope for people with disease that turns tissue to BONE as three drugs enter clinical trial
Three drugs have entered clinical trials as potential therapies for those with fibrodysplasia ossificans progressiva, a genetic condition that turns dasmaged tissue and muscle into bone. (Source: the Mail online | Health)
Source: the Mail online | Health - March 20, 2019 Category: Consumer Health News Source Type: news

Heartbreaking stories of patients battling a rare condition 'that is slowly turning them into stone'
Thozi Mciki, 50, and Damian Fredericks, 18, both from near Cape Town in South Africa, have a rare condition called fibrodysplasia ossificans progressiva which causes muscles to turn to bone. (Source: the Mail online | Health)
Source: the Mail online | Health - October 26, 2018 Category: Consumer Health News Source Type: news

Ballymena sisters have a disease turning them to stone
Zoe Buxton and Lucy Fretwell, 26, from Ballymena, Northern Ireland, have a one-in-two-million condition, called fibrodysplasia ossificans progressiva, which causes bone to replace muscle. (Source: the Mail online | Health)
Source: the Mail online | Health - July 17, 2017 Category: Consumer Health News Source Type: news

Sisters, 26, have a disease that is turning them to STONE
Zoe Buxton and Lucy Fretwell, 26, from Ballymena, Northern Ireland, have a one-in-two-million condition, called fibrodysplasia ossificans progressiva, which causes bone to replace muscle. (Source: the Mail online | Health)
Source: the Mail online | Health - July 17, 2017 Category: Consumer Health News Source Type: news