Foundation for Prader-Willi Blog

FDA Committee Indicates Substantial Evidence Has Not Been Provided For the Effectiveness of Carbetocin as a Treatment for PWS

In a disappointing decision, a panel of independent advisers to the Food and Drug Administration has voted 12 to 1 suggesting that Levo Therapeutics has not provided substantial evidence of effectiveness for carbetocin nasal spray (LV-101) in the tre...

November 4, 2021 Read More

Topics: News

FPWR, FAST, ASF, and Dup15q Unite to Fund Newborn Screening Grant

The Foundation for Prader-Willi Research (FPWR), Foundation for Angelman Syndrome Therapeutics (FAST), Angelman Syndrome Foundation (ASF), and Dup15q Alliance announce a collaborative initiative to fund the addition of chromosome 15 conditions to Ear...

November 2, 2021 Read More

Topics: News, Research

Carbetocin Approval: Your Comment Could Make the Difference

Would you like to be part of our community-wide effort to advocate for new treatments for PWS? The FDA is now accepting comments from the public regarding a new drug application currently under review for LV-101 (intranasal carbetocin), a potential t...

October 14, 2021 Read More

Topics: News, Research

FPWR and PWSA | USA Engage FDA in Patient Listening Session

On June 17, 2021, FPWR and PWSA | USA engaged the FDA in a Patient-Led Listening Session to share our community’s experiences related to Prader-Willi syndrome (PWS). The purpose of this meeting was to promote dialogue between the FDA and members of t...

July 23, 2021 Read More

Topics: News

Radius Health Announces Pivotal Study for Prader-Willi Syndrome

Radius Health announced today their plans for a Pivotal Study for RAD011 for the treatment of hyperphagia in Prader-Willi syndrome. The Phase 2/3 study, SCOUT (Synthetic Cannabidiol Oral Solution), will evaluate safety and tolerability in PWS and is ...

July 22, 2021 Read More

Topics: News

FDA Encourages Submission of Additional Data for DCCR

Soleno Therapeutics has announced that the FDA will accept additional data from their DESTINY PWS and C602 extension study to determine if the data generated are sufficient to support a potential New Drug Application (NDA) for diazoxide choline contr...

July 6, 2021 Read More

Topics: News, Clinical Trials

FDA Grants Priority Review for Levo Therapeutics’ New Drug Application for LV-101 for the Treatment of Prader-Willi Syndrome

Levo Therapeutics has announced the FDA has granted Priority Review for its New Drug Application (NDA) for LV-101 (intranasal carbetocin) as a treatment for hyperphagia and behavioral distress associated with PWS. A 6-month Priority Review will accel...

July 6, 2021 Read More

Topics: News, Clinical Trials

Our First 2021 Venture Philanthropy Investment: Aardvark Therapeutics

In support of our mission to advance the development of new treatments for Prader-Willi syndrome (PWS), FPWR announces our newest venture philanthropy investment in Aardvark Therapeutics.

June 22, 2021 Read More

Topics: News

FPWR and PWSA|USA Request Regulatory Flexibility & Review of NDA for Intranasal Carbetocin

In a continuation of our joint advocacy efforts supporting the full review of potential drugs for PWS, FPWR and PWSA | USA have submitted a petition letter to the FDA requesting that they apply regulatory flexibility and to review a New Drug Applicat...

June 10, 2021 Read More

Topics: News

Foundation for Prader-Willi Blog | News (8)

Categories

FDA Committee Indicates Substantial Evidence Has Not Been Provided For the Effectiveness of Carbetocin as a Treatment for PWS

FPWR, FAST, ASF, and Dup15q Unite to Fund Newborn Screening Grant

Carbetocin Approval: Your Comment Could Make the Difference

FPWR and PWSA | USA Engage FDA in Patient Listening Session

Radius Health Announces Pivotal Study for Prader-Willi Syndrome

FDA Encourages Submission of Additional Data for DCCR

FDA Grants Priority Review for Levo Therapeutics’ New Drug Application for LV-101 for the Treatment of Prader-Willi Syndrome

Our First 2021 Venture Philanthropy Investment: Aardvark Therapeutics

FPWR and PWSA|USA Request Regulatory Flexibility & Review of NDA for Intranasal Carbetocin

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