Showing posts with label Complete Response Letter. Show all posts
Showing posts with label Complete Response Letter. Show all posts

Wednesday, May 1, 2019

FDA Issues Complete Response Letter for Zynquista (sotagliflozin)


In continuation of my update on Zynquista (sotagliflozin)

Image result for Zynquista (sotagliflozin)

 The U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) regarding the New Drug Application for investigational Zynquista (sotagliflozin)*, a dual SGLT1 and SGLT2 inhibitor for the treatment of adults with type 1 diabetes in combination with insulin.
A CRL is a communication from the FDA that informs companies that an application cannot be approved in its present form.
Sanofi and Lexicon will work closely with the FDA to determine the appropriate next steps.

About Lexicon Pharmaceuticals

Lexicon (NASDAQ: LXRX) is a fully integrated biopharmaceutical company that is applying a unique approach to gene science based on Nobel Prize-winning technology to discover and develop precise medicines for patients with serious, chronic conditions. Through its Genome5000™ program, Lexicon scientists have studied the role and function of nearly 5,000 genes over the last 20 years and have identified more than 100 protein targets with significant therapeutic potential in a range of diseases. Through the precise targeting of these proteins, Lexicon is pioneering the discovery and development of innovative medicines to safely and effectively treat disease. In addition to its first commercial product, XERMELO® (telotristat ethyl), Lexicon has a pipeline of promising drug candidates in clinical and pre-clinical development in diabetes and metabolism and neuropathic pain. For additional information please visit www.lexpharma.com.
*Sotagliflozin is an investigational drug and is under regulatory review by the European Medicines Agency (EMA) and U.S. Food and Drug Administration (FDA). The EMA and FDA have conditionally accepted Zynquista™ as the trade name for sotagliflozin.

https://pubchem.ncbi.nlm.nih.gov/compound/lx-4211#section=Structures


Wednesday, March 13, 2019

Sunovion Receives Complete Response Letter from FDA for Apomorphine Sublingual Film (APL-130277)

 Sunovion Pharmaceuticals Inc. (Sunovion) announced today that the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) for the New Drug Application (NDA) for apomorphine sublingual film (APL-130277) to treat OFF episodes (the re-emergence or worsening of Parkinson’s symptoms otherwise controlled by medications) experienced by people living with Parkinson’s disease (PD).

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Upon review of the application, the FDA determined that it was unable to approve the apomorphine sublingual film NDA in its present form. The Agency requested additional information and analyses, but no new clinical studies are required.
“OFF episodes are a common and challenging part of Parkinson’s disease with few existing treatment options,” said Antony Loebel, M.D., Executive Vice President and Chief Medical Officer at Sunovion, Head of Global Clinical Development for Sumitomo Dainippon Pharma Group. “Sunovion remains committed to working with the FDA to address its requests so that we can bring apomorphine sublingual film to patients as expeditiously as possible.”

About Apomorphine Sublingual Film (APL-130277)

APL-130277, a novel formulation of apomorphine and a dopamine agonist, is being developed for the on-demand management of OFF episodes associated with Parkinson’s disease (PD). Apomorphine is currently FDA approved for the acute, intermittent treatment of hypomobility, “OFF” episodes (“end-of-dose wearing OFF” and unpredictable “ON/OFF” episodes) associated with advanced PD, and it is currently available in the U.S. as a subcutaneous injection. APL-130277 is intended to rapidly convert people living with PD from the OFF to the ON state and has been studied for treatment of motor OFF episodes up to five times per day and no sooner than two hours from the previous dose. APL-130277 has not been approved by the FDA. In October 2016, Sunovion acquired Cynapsus Therapeutics Inc. along with its product candidate APL-130277. The Michael J. Fox Foundation funded in part two Phase I trials of APL-130277 – a comparative biostudy in healthy volunteers and a dosing study in people with Parkinson's disease.

Tuesday, November 13, 2018

Sunovion receives Complete Response Letter from FDA for dasotraline NDA

Sunovion Pharmaceuticals Inc. (Sunovion) today announced that the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter for the New Drug Application (NDA) for dasotraline, a novel dual-acting dopamine and norepinephrine reuptake inhibitor (DNRI), for the treatment of attention-deficit hyperactivity disorder (ADHD).

Dasotraline.svg
Upon completion of their review, the FDA determined that they cannot approve the dasotraline NDA for the treatment of ADHD in its current form. The Agency indicated that additional clinical data are needed to further evaluate the efficacy and tolerability of dasotraline for the treatment of ADHD. Sunovion plans to meet with the FDA to discuss their comments and determine next steps.
Dasotraline was evaluated in approximately 2,500 children and adults with ADHD in multiple placebo-controlled safety and efficacy studies, as well as two long-term safety studies.
"While we are disappointed with the FDA's decision, we remain confident in the future of dasotraline," said Antony Loebel, M.D., Executive Vice President and Chief Medical Officer at Sunovion, Head of Global Clinical Development for Sumitomo Dainippon Pharma Group. "We plan to discuss next steps for the dasotraline ADHD program with the FDA as soon as possible."
Dasotraline is also being studied for the treatment of moderate to severe binge eating disorder (BED) in adults in the U.S. Data from two positive pivotal studies will support an expected marketing application submission to the FDA for dasotraline to treat BED in FY2018.​
Ref : https://news.sunovion.com/press-release/fda-issues-complete-response-letter-new-drug-application-dasotraline-treatment-adhd
https://en.wikipedia.org/wiki/Dasotraline