Australian biopharmaceutical company Specialised Therapeutics (ST) announced on Thursday the Australian registration of SKYTROFA (lonapegsomatropin) as a new once-weekly injectable therapy for paediatric growth hormone deficiency (GHD).

The Therapeutic Goods Administration (TGA) has approved SKYTROFA as a treatment for 'growth failure in children and adolescents aged from 3 years up to 18 years due to insufficient endogenous growth hormone secretion'.

SKYTROFA is being registered in Australia by ST under an exclusive distribution agreement with biopharmaceutical company Ascendis Pharma A/S (NASDAQ:ASND) that covers Australia, New Zealand, Singapore, Malaysia, Brunei, Thailand and Vietnam.

The Australian registration of SKYTROFA follows approvals issued to Ascendis Pharma by the US Food and Drug Administration (US FDA) in August 2021 and the European Medicines Agency (EMA) in January 2022.

Developed using Ascendis Pharma's proprietary TransCon platform, SKYTROFA is delivered as a subcutaneous injection, available in various strengths. The TGA registration of SKYTROFA was based on the results of Ascendis Pharma's three pivotal Phase 3 clinical trials, which collectively treated more than 300 paediatric patients diagnosed with GHD, including from Australia.