Ascendis Pharma Submits Application for Adult Growth Hormone Treatment
Ascendis Pharma Submits Supplemental Application for TransCon hGH
Ascendis Pharma A/S (Nasdaq: ASND) has recently made waves in the biopharmaceutical arena by submitting a supplemental Biologics License Application (sBLA) to the U.S. Food & Drug Administration (FDA). This application is specifically for TransCon hGH, also known in the U.S. as SKYTROFA, which is currently used to treat pediatric growth hormone deficiency. The latest submission aims to extend this groundbreaking treatment to adults who suffer from growth hormone deficiency (GHD).
Why TransCon hGH is a Game Changer for Adults
Jan Mikkelsen, President and CEO of Ascendis Pharma, is optimistic about the potential of TransCon hGH to become a blockbuster product. He emphasized that growth hormone is crucial for human health across the lifespan. Research indicates that many adults living with growth hormone deficiency remain untreated. Mikkelsen believes that once-weekly TransCon hGH could offer a substantial new treatment option that addresses an essential unmet medical need.
The ForesiGHt Clinical Trial
The sBLA submission is informed by recent findings from a significant clinical study known as foresiGHt. This Phase 3 trial was meticulously designed with randomized, parallel-arm, and double-blind methodologies, comparing the efficacy and safety of TransCon hGH against a weekly placebo and daily growth hormone administration among adults aged 23 to 80. In total, 259 participants were evaluated, receiving treatment protocols tailored to their specific age and estrogen consumption habits.
Positive Results and Safety Profile
The results of the foresiGHt trial are promising. TransCon hGH demonstrated superior efficacy on its primary and key secondary endpoints after 38 weeks of treatment. Patients receiving TransCon hGH exhibited statistically significant improvements in trunk fat reduction and total body lean mass compared to those on the placebo. Additionally, the safety profile of TransCon hGH was reassuring, with no study drug discontinuations reported and a safety tolerance comparable to daily growth hormone therapy.
Looking at Adult Growth Hormone Deficiency
Understanding the impact of adult growth hormone deficiency is critical. Growth hormone's role is paramount; it not only facilitates protein production and muscle mass development but also regulates fat usage and blood sugar levels. Adults with GHD can experience a host of symptoms including central obesity, metabolic syndrome, reduced bone density, and a range of psychological issues like cognitive decline and social withdrawal. Therefore, targeted treatment through TransCon hGH could profoundly enhance patients’ quality of life.
About Ascendis Pharma’s Vision
Ascendis Pharma is dedicated to leveraging its advanced TransCon technology platform to establish itself as a leader in the biopharmaceutical industry. The company’s mission is to create innovative solutions that can significantly improve the lives of patients. With a commitment to its core values—Patients, Science, and Passion—Ascendis aspires to make substantial advancements in healthcare across the globe. Headquartered in Copenhagen, Ascendis Pharma is making strides not only in Europe but also within the United States.
Frequently Asked Questions
What is the significance of the supplemental application by Ascendis Pharma?
The application aims to extend the use of TransCon hGH, currently approved for pediatric patients, to adults suffering from growth hormone deficiency.
How does TransCon hGH differ from traditional growth hormone treatments?
TransCon hGH is administered once weekly, potentially offering greater convenience and improved adherence compared to daily treatments.
What were the key findings from the foresiGHt trial?
The trial showed that TransCon hGH provided significant benefits in terms of fat reduction and lean body mass improvement for patients after 38 weeks of treatment.
What are the common symptoms of adult growth hormone deficiency?
Symptoms include central obesity, decreased bone density, fatigue, cognitive impairment, and social isolation among others.
How does Ascendis Pharma plan to develop its product portfolio?
Ascendis Pharma intends to utilize its innovative TransCon platform to create new therapies that address various unmet medical needs in patient populations.
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