Last Updated on December 31, 2023 by The Health Master
Bengaluru: Denmark-based Ascendis Pharma A/S said the US Food & Drug Administration (USFDA) had declined to approve its experimental therapy to treat adult patients with a hormone disorder called hypoparathyroidism, citing concerns related to manufacturing control of the drug and device combination.
The agency, however, did not express concerns about the clinical data submitted and did not seek fresh pre-clinical or late-stage trials in a so-called complete response letter, the company said.
Ascendis’ US-listed shares rose 12 per cent in premarket trade. The USFDA, early last month, had identified unspecified deficiencies in the company’s application for approval of the therapy, TransCon PTH.
TD Cowen analyst Yaron Werber had raised concerns about the lack of clarity around USFDA’s decision in a note on Friday.
He said a complete response letter declining approval was likely, adding the stock will slump if the USFDA sought another pre-clinical or clinical study as this would delay approval by 1.5-2 years.
USFDA declines to approve this Lung Cancer drug
USFDA declines to approve expanded use of this Antipsychotic drug
USFDA declines to approve this Urinary Tract Infection Drug
USFDA declines to approve this Anti-seizure drug
USFDA declines to authorise this viral skin disease treatment
USFDA declines pediatric EUA for vaccine Covaxin
USFDA issues Form 483 with 3 observation to Zydus, Ahmedabad
Govt allows NIB to conduct more tests on Medical Devices
USFDA gives approval for next generation Pneumococcal Vaccine
Relabeling of drug prices based on recent price changes in NLEM products
Drug recall: Thyronorm tablets recalled due to this reason
Govt likely to announce National Medical Device Policy
Drug alert: 48 out of 1497 samples declared as NSQ in March 2023
Wet Granulation vs Dry Granulation: Understanding the Key Differences
For informative videos by The Health Master, click on the below YouTube icon:
For informative videos on Medical Store / Pharmacy, click on the below YouTube icon:
For informative videos on the news regarding Pharma / Medical Devices / Cosmetics / Homoeopathy etc., click on the below YouTube icon:
For informative videos on consumer awareness, click on the below YouTube icon:
