ASND: Gets European Approval for hGH
Jan 13, 2022 13:54:00 GMT
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Post by icemandios on Jan 13, 2022 13:54:00 GMT
Ascendis Pharma A/S Receives European Approval for TransCon™ hGH for Pediatric Growth Hormone Deficiency
TransCon hGH (approved by the European Commission as Lonapegsomatropin Ascendis Pharma) is a once-weekly prodrug of somatropin for pediatric patients diagnosed with growth hormone deficiency
COPENHAGEN, Denmark, Jan. 13, 2022 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today announced that the European Commission (EC) has granted marketing authorization for Lonapegsomatropin Ascendis Pharma (developed under the name TransCon hGH) as a once-weekly subcutaneous injection for the treatment of children and adolescents ages 3 to 18 years with growth failure due to insufficient secretion of endogenous growth hormone (also known as growth hormone deficiency, or GHD). TransCon hGH is a prodrug of somatropin that provides sustained release of unmodified somatropin (hGH) at predictable therapeutic levels in the body.
“We aim to build a leading global brand for TransCon hGH and are proud to have the first once-weekly growth hormone replacement for pediatric GHD approved in both the European Union and the United States,” said Jan Mikkelsen, Ascendis Pharma President and CEO. “With this approval as a starting point, we look forward to bringing a broad portfolio of TransCon products to physicians and patients in Europe.”
The EC approval is based on clinical results submitted in the Marketing Authorisation Application (MAA), including data from the Company’s Phase 3 heiGHt, fliGHt and enliGHten Trials, which collectively treated more than 300 pediatric patients diagnosed with GHD, as well as data from a non-clinical safety program.
In August 2021, the U.S. Food & Drug Administration approved TransCon hGH for the treatment of pediatric patients one year and older who weigh at least 11.5 kg and have growth failure due to inadequate secretion of endogenous growth hormone. TransCon hGH is also in development for pediatric GHD in Japan and China.
About Pediatric Growth Hormone Deficiency
Pediatric GHD is a serious orphan disease caused when the pituitary gland does not produce enough growth hormone. Physiological levels of growth hormone are required for overall endocrine health and development of healthy bone, muscle, and adipose tissue. Children with GHD are characterized by short stature and may also experience metabolic abnormalities, psychosocial challenges, and an overall poor quality of life. For decades, the standard of care for GHD has been a daily subcutaneous injection of somatropin to improve growth and overall endocrine health.
About Ascendis Pharma A/S
Ascendis Pharma is applying its innovative platform technology to build a leading, fully integrated biopharma company focused on making a meaningful difference in patients’ lives. Guided by its core values of patients, science and passion, the company uses its TransCon technologies to create new and potentially best-in-class therapies. Ascendis is headquartered in Copenhagen, Denmark, and has additional facilities in Heidelberg and Berlin, Germany; Palo Alto and Redwood City, California; and Princeton, New Jersey. Please visit www.ascendispharma.com to learn more.
TransCon hGH (approved by the European Commission as Lonapegsomatropin Ascendis Pharma) is a once-weekly prodrug of somatropin for pediatric patients diagnosed with growth hormone deficiency
COPENHAGEN, Denmark, Jan. 13, 2022 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today announced that the European Commission (EC) has granted marketing authorization for Lonapegsomatropin Ascendis Pharma (developed under the name TransCon hGH) as a once-weekly subcutaneous injection for the treatment of children and adolescents ages 3 to 18 years with growth failure due to insufficient secretion of endogenous growth hormone (also known as growth hormone deficiency, or GHD). TransCon hGH is a prodrug of somatropin that provides sustained release of unmodified somatropin (hGH) at predictable therapeutic levels in the body.
“We aim to build a leading global brand for TransCon hGH and are proud to have the first once-weekly growth hormone replacement for pediatric GHD approved in both the European Union and the United States,” said Jan Mikkelsen, Ascendis Pharma President and CEO. “With this approval as a starting point, we look forward to bringing a broad portfolio of TransCon products to physicians and patients in Europe.”
The EC approval is based on clinical results submitted in the Marketing Authorisation Application (MAA), including data from the Company’s Phase 3 heiGHt, fliGHt and enliGHten Trials, which collectively treated more than 300 pediatric patients diagnosed with GHD, as well as data from a non-clinical safety program.
In August 2021, the U.S. Food & Drug Administration approved TransCon hGH for the treatment of pediatric patients one year and older who weigh at least 11.5 kg and have growth failure due to inadequate secretion of endogenous growth hormone. TransCon hGH is also in development for pediatric GHD in Japan and China.
About Pediatric Growth Hormone Deficiency
Pediatric GHD is a serious orphan disease caused when the pituitary gland does not produce enough growth hormone. Physiological levels of growth hormone are required for overall endocrine health and development of healthy bone, muscle, and adipose tissue. Children with GHD are characterized by short stature and may also experience metabolic abnormalities, psychosocial challenges, and an overall poor quality of life. For decades, the standard of care for GHD has been a daily subcutaneous injection of somatropin to improve growth and overall endocrine health.
About Ascendis Pharma A/S
Ascendis Pharma is applying its innovative platform technology to build a leading, fully integrated biopharma company focused on making a meaningful difference in patients’ lives. Guided by its core values of patients, science and passion, the company uses its TransCon technologies to create new and potentially best-in-class therapies. Ascendis is headquartered in Copenhagen, Denmark, and has additional facilities in Heidelberg and Berlin, Germany; Palo Alto and Redwood City, California; and Princeton, New Jersey. Please visit www.ascendispharma.com to learn more.