Last Updated on December 21, 2024 by The Health Master
USFDA
In a significant setback for Swedish drugmaker Camurus, the U.S. Food and Drug Administration (USFDA) has declines to approve the company’s application for a new drug for the treatment of a rare hormonal disorder.
The decline, announced late Monday, is due to deficiencies at a third-party manufacturing facility.
The Impact on Patients with Acromegaly
The USFDA’s decline could delay the approval and subsequent launch of the drug, CAM2029, which is intended for the treatment of patients with acromegaly.
This rare condition, affecting only 3 to 14 people per 100,000, is characterized by excessive growth hormone production.
Camurus’ Response to the USFDA’s Decision
Camurus CEO Fredrik Tiberg expressed disappointment in the USFDA’s decline but remained optimistic about the drug’s potential to address the unmet medical needs of patients with acromegaly.
The company emphasized the strong data supporting its New Drug Application (NDA) and the positive impact CAM2029 could have on patients.
Market Reaction to the USFDA’s decline
Following the USFDA’s announcement, Camurus’ shares experienced a significant decline of 10% in Stockholm trading.
This market reaction reflects the potential financial impact of the delayed drug approval on the company.
Potential Delays in Drug Launch
Analysts at Jefferies have estimated that the manufacturing issues could delay the approval of Oclaiz, the drug’s brand name, by six months to one year.
This would push its potential launch to the fourth quarter of 2025.
Disclaimer: This article contains information derived from the source mentioned below. Our team utilized an AI language model to rewrite and present the news or article in a unique format.
Disclaimer: This content, provides generic information only. It is in no way a substitute for a qualified medical opinion. Always consult a specialist or your own doctor for more information. The Health Master does not claim responsibility for this information.
USFDA declines to approve this drug for low blood sugar in infants
USFDA declines to approve this Nasal Spray
USFDA declines to approve this weekly Insulin
USFDA declines to approve this migraine drug
USFDA declines to approve Nasal Spray for allergic reactions
DTAB recommends Stricter Qualifications for Wholesale Drug Licenses
Price fixation of Wysolone DT Tablets: Review application rejected
Two new Drug Testing Laboratories open: Gujarat FDCA
Streamlining Pharma Exports: DGFT Introduces Electronic Submission system
DTAB agrees with proposal to amend New Drugs and Clinical Trials Rules
Drug recall: Gilead recalled this drug after failed trial
FSSAI: Food Labelling and Display – Chapter-11
USFDA approval granted for Fludrocortisone Acetate Tablets
Gujarat FDCA empowers Officers to enforce Revised Schedule M
Govt asks NPPA to recalculate ceiling price of Thiamine Injection
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:
