Ascendis Pharma Opens Compassionate Use Program for TransCon PTH (palopegteriparatide) in Germany
– Compassionate use enables treating physicians in Germany to request access to investigational TransCon PTH (palopegteriparatide) for eligible adult patients with hypoparathyroidism
COPENHAGEN, Denmark, June 05, 2023 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today announced that it has started enrollment for a Compassionate Use Program (CUP) in Germany for TransCon PTH (palopegteriparatide), an investigational prodrug designed to provide sustained release of active parathyroid hormone (PTH 1-34) within the physiological range for 24 hours per day in adult patients with hypoparathyroidism with once-daily administration. The CUP was approved by Germany’s Federal Institute for Drugs & Medical Devices (Bundesinstitut für Arzneimittel & Medizinprodukte, or BfArM).
“We are pleased to offer this pre-approval Compassionate Use Program for TransCon PTH for eligible patients in Germany to address the unmet medical needs of this patient community,” said Moritz Meissner, M.D., Ascendis Pharma’s Head of Medical Affairs Germany. “Because therapy with oral calcium and active vitamin D aims to control and alleviate hypocalcemic symptoms in patients but does not address the underlying cause of hypoparathyroidism – and importantly, does not address PTH physiology and may itself be associated with secondary complications – we remain committed to advancing potential new treatment options for this disease.”
Through the CUP, treating physicians can request TransCon PTH (palopegteriparatide) for eligible adult patients with hypoparathyroidism whose clinical condition, in the opinion of the treating physician, requires PTH treatment with palopegteriparatide, and who cannot be adequately treated with currently approved products or participate in a palopegteriparatide clinical trial.
Physicians in Germany who are interested in the TransCon PTH (palopegteriparatide) CUP can request full information and initiate enrollment by contacting email@example.com.
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About Compassionate Use in Germany
In Germany, access to medicinal products that have not yet received marketing authorization may be allowed if sufficient indications of the efficacy and safety of the medicinal product exist and if a clinical trial is being conducted on it, or if an application for a marketing authorization has been submitted to the European Medicines Agency (EMA). Information on current compassionate use programs in Germany can be found on the website of the Federal Institute for Drugs & Medical Devices (Bundesinstitut für Arzneimittel & Medizinprodukte, or BfArM) here.