#EMDAC - Twitter Hashtag

over 3 years ago

Yesterday was exciting! A drug to treat #FOP has never made it this far @US_FDA. Now #palovarotene has been recommended by #EMDAC for approval. Remember: this is just the Committee's recommendation & does NOT guarantee FDA approval. We'll know FDA's decision by August 16, 2023.

ifopa's tweet photo. Yesterday was exciting! A drug to treat #FOP has never made it this far @US_FDA. Now #palovarotene has been recommended by #EMDAC for approval. Remember: this is just the Committee's recommendation & does NOT guarantee FDA approval. We'll know FDA's decision by August 16, 2023. https://t.co/aDCdl1wtrK

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IFOPA @ifopa

over 3 years ago

It's a yes on 2: Do the benefits of #palovarotene outweigh its risks for the treatment of patients with FOP? However, this does NOT mean it is approved. This is only a vote by the #EMDAC that the @us_fda will consider when making their final decision 8/16

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IFOPA @ifopa

over 3 years ago

It's a yes on 1: Does the evidence from Study 301 of palovarotene's treatment effect show the drug is effective in patients with FOP? However, this does NOT mean it is approved. This is only a vote by the #EMDAC that the @us_fda will consider when making their final decision 8/16

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IFOPA @ifopa

over 3 years ago

We’ve been through more than we ever anticipated in these last 17 years. It’s probably too late for Erin but I wouldn't want another family to go through what we've been through. --Suzanne McCloskey, mom to Erin who lives with FOP #EMDAC #FDA #palovarotene #FOP #ADCOM

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IFOPA @ifopa

over 3 years ago

If there was an available drug that could slow the growth of FOP bone, people living with this disease would have a better opportunity for more normal respiratory health and nutrition. --Ellen Elias, MD, Children's Hospital Colorado #AdCom #FDA #FOP #EMDAC #palovarotene

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IFOPA @ifopa

over 3 years ago

Dr. Ed Hsiao, #FOP expert & member of International Clinical Council on FOP, states that benefits of #palovarotene outweigh risks, but does remind us that it is not for all people with FOP. The risks must be considered for each patient. #EMDAC #FDA #ADCOM @US_FDA @IpsenUS

ifopa's tweet photo. Dr. Ed Hsiao, #FOP expert & member of International Clinical Council on FOP, states that benefits of #palovarotene outweigh risks, but does remind us that it is not for all people with FOP. The risks must be considered for each patient.
#EMDAC #FDA #ADCOM @US_FDA @IpsenUS https://t.co/3U9EHb485q

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IFOPA @ifopa

over 3 years ago

The #palovarotene clinical development program has included 25% of the known population of people living with #FOP in the world. -Howard Mayer, MD, EVP and Head of Research & Development @IpsenUS #EMDAC #FDA #ADCOM

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IFOPA @ifopa

over 3 years ago

BIG DAY ahead! The Advisory Committee Meeting is June 28, and here's how it's going to happen: - Presentation by @IpsenUS - Presentation by the @US_FDA - Open Public Hearing (2 - 3 pm ET) - Committee discussion - The vote #AdCom #FDA #FOP #EMDAC #palovarotene

ifopa's tweet photo. BIG DAY ahead! The Advisory Committee Meeting is June 28, and here's how it's going to happen:
- Presentation by @IpsenUS
- Presentation by the @US_FDA
- Open Public Hearing (2 - 3 pm ET)
- Committee discussion
- The vote
#AdCom #FDA #FOP #EMDAC #palovarotene https://t.co/bFWvA7kzhp

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IFOPA @ifopa

over 3 years ago

The FOP community showed up BIG to tell the @USFDA what it's like to live with #FOP. You sent in letters from all around the world 🌎 THANK YOU for taking the time & making the effort. Your voice is so very important! #EMDAC #palovarotene #AdCom #FDA #FOP

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Healio @GoHealio

over 5 years ago

An @US_FDA advisory committee voted 10-7 in favor of recommending the immunotherapy #teplizumab to delay the development of type 1 diabetes by high-risk children and adults. @FDAadcomm @ProventionBio #T1D #EMDAC #teplizumab https://t.co/RhbRRDRwBl

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Endocrine Today @EndocrineToday

over 5 years ago

An @US_FDA advisory committee voted 10-7 in favor of recommending the immunotherapy #teplizumab to delay the development of type 1 diabetes by high-risk children and adults. @FDAadcomm @ProventionBio #T1D #EMDAC #teplizumab https://t.co/K6apV9U2DK

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kelly close @kellyclose

over 5 years ago

Talking about delay sure brought a lot of light to all #diabetes. Beautiful #emdac close by @US_FDA’s Dr Yanoff to this riveting #teplizumab CDER mtg. @annamctweet @JDRF @dQAresearch @TCOYD @CollegeDiabetes @cwdiabetes @Stanford @diaTribeNews @uflorida @CDN_CEO @UCSDHealth #T1D +

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kelly close @kellyclose

over 5 years ago

So close ~ 10-7 for the yes vote for @ProventionBio’s anti-Cd3. V important + qualified opinions for @US_FDA + v key narrow opinion advice to CDER. Will be so key to watch next what leader Dr Yanoff does. She is brilliant + is getting v valuable advice. #emdac #teplizumab #hope

kellyclose's tweet photo. So close ~ 10-7 for the yes vote for @ProventionBio’s anti-Cd3. V important + qualified opinions for @US_FDA + v key narrow opinion advice to CDER. Will be so key to watch next what leader Dr Yanoff does. She is brilliant + is getting v valuable advice. #emdac #teplizumab #hope https://t.co/lZKrkwLM7a

kelly close @kellyclose

over 5 years ago

Lots happening at @US_FDA and #emdac. Grateful to be part of getting to share #pwd views + so appreciate collaboration + so much from #pwd + esp @annamctweet + @jdrf. Ty @dQAresearch + @JDRF + @TCOYD + @diaTribeNews + so many more. #EMDAC #voting

kellyclose's tweet photo. Lots happening at @US_FDA and #emdac. Grateful to be part of getting to share #pwd views + so appreciate collaboration + so much from #pwd + esp @annamctweet + @jdrf. Ty @dQAresearch + @JDRF + @TCOYD + @diaTribeNews + so many more. #EMDAC #voting https://t.co/yYQ35z784c

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Sue Sutter @PinkSheetSutter

over 5 years ago

$PRVB teplizumab - @US_FDA #EMDAC votes 10-7 that benefits outweigh risks for delaying type 1 diabetes

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kelly close @kellyclose

over 5 years ago

Lots happening at @US_FDA and #emdac. Grateful to be part of getting to share #pwd views + so appreciate collaboration + so much from #pwd + esp @annamctweet + @jdrf. Ty @dQAresearch + @JDRF + @TCOYD + @diaTribeNews + so many more. #EMDAC #voting

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Amarin

@Amarincorp

about 7 years ago

FDA’s Endocrinologic and Metabolic Drugs Advisory Committee recommends approval for expanded use of Amarin’s therapy. Read more here: https://t.co/QdJocb49zk #hearthealth #AMRN #EMDAC

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Sue Sutter @PinkSheetSutter

about 7 years ago

#EMDAC views on indication breadth - By my count, 10 members strongly in favor of approval for both secondary and primary prevention; 4 opposed for primary prevention; 2 on fence about primary

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kelly close @kellyclose

about 7 years ago

16-0 vote shows resounding support from #EMDAC committee for approval of #Amarin’s #Vascepa . While it’s still not determined whether this‘ll be available to all #pwd or just those w/established CVD, we are excited for @US_FDA to decide on primary prevention Qs. #WorldDiabetesDay

kellyclose's tweet photo. 16-0 vote shows resounding support from #EMDAC committee for approval of #Amarin’s #Vascepa . While it’s still not determined whether this‘ll be available to all #pwd or just those w/established CVD, we are excited for @US_FDA to decide on primary prevention Qs. #WorldDiabetesDay https://t.co/sGEYLPQeic

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kelly close @kellyclose

about 7 years ago

@annamctweet gets incredible round of applause for her words at @US_FDA - she always, always brings up the critical issues surrounding access. She was v instrumental in the 16-0 vote, and #pwd will have such an easier time. #Vascepa #EMDAC #WorldDiabetesDay

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Sue Sutter @PinkSheetSutter

about 7 years ago

@US_FDA #EMDAC vote on $AMRN #Vascepa label expansion for CV risk reduction – Y - 16, N – 0

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