ASND: TransCon hGH 2021 Results
Mar 3, 2022 15:42:17 GMT
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Post by icemandios on Mar 3, 2022 15:42:17 GMT
TransCon hGH:
In fall-2021, the Company commercially launched in the U.S., TransCon hGH under the brand name of SKYTROFA (lonapegsomatropin-tcgd), the only FDA-approved once-weekly treatment for 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. As of February 28, 2022, 708 SKYTROFA prescriptions were written by approximately 263 prescribers, including 44% writing prescriptions for multiple patients.
In January 2022, the Company received marketing authorization for Lonapegsomatropin Ascendis Pharma (developed under the brand name of TransCon hGH) in the European Union 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.
Plan to submit a protocol to the FDA to evaluate TransCon hGH for Turner Syndrome in the second quarter of 2022. The Company expects to evaluate higher doses of TransCon hGH and daily growth hormone for Turner Syndrome compared to those doses for pediatric or adult GHD.
The ongoing conflict in the region surrounding Ukraine and Russia has impacted our ability to continue clinical trial activities in those countries. While this may affect our timelines for the foresiGHt Trial, our Phase 3 trial in adult growth hormone deficiency, there is currently no material impact to our business from this situation.
In fall-2021, the Company commercially launched in the U.S., TransCon hGH under the brand name of SKYTROFA (lonapegsomatropin-tcgd), the only FDA-approved once-weekly treatment for 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. As of February 28, 2022, 708 SKYTROFA prescriptions were written by approximately 263 prescribers, including 44% writing prescriptions for multiple patients.
In January 2022, the Company received marketing authorization for Lonapegsomatropin Ascendis Pharma (developed under the brand name of TransCon hGH) in the European Union 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.
Plan to submit a protocol to the FDA to evaluate TransCon hGH for Turner Syndrome in the second quarter of 2022. The Company expects to evaluate higher doses of TransCon hGH and daily growth hormone for Turner Syndrome compared to those doses for pediatric or adult GHD.
The ongoing conflict in the region surrounding Ukraine and Russia has impacted our ability to continue clinical trial activities in those countries. While this may affect our timelines for the foresiGHt Trial, our Phase 3 trial in adult growth hormone deficiency, there is currently no material impact to our business from this situation.
Ascendis Pharma A/S Reports Full Year 2021 Financial Results and Provides a Business Update
