Steadymed Ltd (NASDAQ:STDY) has received final minutes from the US Food and Drug Administration (FDA) detailing what is required in resubmitting its New Drug Application (NDA). The specialty pharmaceutical company is seeking an approval of Trevyent, a treatment for Pulmonary Arterial Hypertension (PAH).
The company may not have to carry out any clinical trials but it may have to answer American regulators’ questions regarding the effectiveness of Trevyent. SteadyMed’s original application which was covering both the therapy and the delivery device had been submitted in July 2017. However, the company has embraced the need for New Drug Application and it anticipates to finish the performance testing in mid-2018.
The introduction of in vitro DV testing Instead of fresh clinical trials, SteadyMed has been allowed by the FDA to repeat its in vitro Design Verification (DV) testing. This will be particularly be done on the in vitro Design Verification (DV) testing. The primary role of in vitro DV testing is to ascertain that Trevyent presentation meets its design specifications.
Nonetheless, SteadyMed has begun the pre-DV activities. Speaking about the latest outcome, President, and CEO of SteadyMed, Jonathan M. N. Rigby said, “We have clarity on the work that needs to be done and are confident that our agreed path forward will lead to a resubmission and acceptance for filing of the Trevyent NDA”.
A sneak peek into SteadyMed
The company’s focus is mainly on the development of drug product candidates, which treat orphan and high-value diseases. On the other hand, it aims at commercializing Trevyent in the U.S. The single-use disposable infusion system is already being commercialized in Europe, Canada, and the Middle East, thanks to CARDIOME PHARMA CORP (NASDAQ:CRME).
CEO and President of Cardiome, William Hunter is optimistic that Trevyent NDA will get positive development. He adds that Trevyent represents is in a better position to deliver treprostinil to patients around the world. In any case, the company has commercial presence and distribution network in over 60 countries worldwide. Cardiome’s effort is on providing innovative and high-quality brands, which will meet the needs of acute care physicians and patients.