Pharmaceutical Technology·· 7 days agoPickScore70
FDA approves Teva’s monthly injection of olanzapine for schizophrenia
In brief
Teva announced FDA approval of Weltruza, a once-monthly subcutaneous long-acting injectable olanzapine for schizophrenia. Approval was based on Phase III SOLARIS trial data (NCT05693935). Weltruza uses Medincell copolymer sustained-release technology and comes in 318mg, 425mg and 531mg doses corresponding to oral 10mg, 15mg and 20mg, with no loading dose, oral supplementation or post-injection monitoring required. It launches in the US within weeks.
Why it matters
Approved on Phase III SOLARIS data, monthly dosing without loading doses or post-injection monitoring offers an alternative for patients with poor long-term adherence.
Source: Pharmaceutical Technology · pharmaceutical-technology.com