Tag Archives: teplizumab

Teplizumab Adcom: 10-7 Split Vote; Questions Raised on Teplizumab’s Approvability

Today, FDA held an advisory committee meeting to discuss the proposed teplizumab indication to delay the onset of T1DM based on results from the TN-10 study. The panel narrowly voted in favor (10-7) that the teplizumab benefits outweigh the risks. Recall, ahead of the adcom, FENIX correctly predicted a 10-7 vote favoring teplizumab. Below, FENIX provides a summary of key adcom panelist commentary as well as thoughts on the vote and next steps for Provention Bio and teplizumab.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

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Provention Bio Teplizumab Adcom Pre-read Materials Posted

FDA posted the pre-read materials for the upcoming teplizumab advisory committee meeting on May 27, 2021 at 9AM EST. Of note, it is believed this is the first time the intended marketed name for teplizumab, “Tzield,” has been disclosed. While it remains to be seen, FENIX predicts a split adcom vote (10-7 favoring teplizumab) due to questions around the clinical meaningfulness of a 2-year delay in the context of the SAEs, including immunosuppression. Below, FENIX provides a brief overview of the key points the panel will consider as well as preliminary thoughts on the adcom.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

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Purchase Blast$599.00

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Lilly Connected Pen Update; Novo Q1 ’21 Post-earnings Event; Provention Bio, BD, ICPT, and REGN Earnings Updates

A series of cardiometabolic-related news items have been observed: Lilly provided an update on its connected pen development, including the disclosure of the Tempo Smart Button (view press release); Novo Nordisk hosted its post-Q1 ’20 earnings event (see previous FENIX insight on Q1 ’21 Novo earnings from May 5); Provention Bio (press release), Becton Dickinson (press release), Intercept (press release; slides) and Regeneron (press release) hosted their respective CY Q1 ’21 earnings calls. Below, FENIX provides highlights and insights from the respective news items, including thoughts on BD’s decision to spin off its diabetes business.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

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Purchase Blast$599.00

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Lilly and Novartis Q1 ’21 Earnings Updates; New Trulicity TV DTC; Provention Meets with FDA

A series of cardiometabolic-related news items have been observed: Lilly and Novartis hosted their respective Q1 ’21 earnings calls; Lilly has initiated a new Trulicity DTC campaign; and Provention Bio announced it met with FDA on April 23, 2021 to discuss the ongoing teplizumab PK comparability issue. Importantly, Lilly disclosed that SURPASS-4 has accrued all of its pre-specified CV events and the trial is scheduled to close out in May with topline results expected by the end of Q2 ’21. Recall, Lilly has previously stated SURPASS 4 is the gating factor for tirzepatide T2DM global regulatory submissions later in 2021. Below, FENIX provides highlights and insights for the respective items.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

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Purchase Blast$599.00

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Provention Bio Delay Appears Inevitable; Better Therapeutics To Go Public; Dexcom G6 Direct Distribution in the Netherlands; Sanofi Furthers Social Responsibility Outreach; Medtronic Commits to Three Initiatives to Address Healthcare Equity; Expanded Access to CGM and Insulin Pumps in Canada

A series of cardiometabolic-related news items have recently been observed from Provention Bio, Better Therapeutics, Dexcom, Sanofi, Medtronic, and JDRF Canada. Below, FENIX provides highlights and insights for the respective news items, including thoughts on how bad the teplizumab delay may really be.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

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Purchase Blast$599.00

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Senseonics Q4 ’20 Earnings Update; Provention Bio Extended Follow-up Data Published; Voluntis Collaborates with Zendesk for Global Customer Support

A series of diabetes-related news items have been observed: Senseonics hosted its Q4 and FY ’20 earnings call; Provention Bio announced the extended follow-up data from the pivotal “At-Risk” TN-10 Study has been published in Science Translational Medicine; and Voluntis announced a collaboration with Zendesk to upgrade its global customer support infrastructure. Below, FENIX provides highlights and insights for the respective news items.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

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Purchase Blast$599.00

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Provention Bio Completes Teplizumab BLA Submission

Provention Bio announced it completed the teplizumab rolling BLA submission for the prevention of T1DM in at-risk patients. Recall, in August 2020, FDA granted Breakthrough Therapy Designation for the teplizumab T1DM prevention indication. Below, FENIX provides thoughts on the potential Provention Bio missed filing deadline opportunity.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

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Purchase Blast$599.00

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Provention Bio Launches T1DM Screening Awareness Campaign

Provention Bio announced that yesterday, the company launched a national campaign to bring awareness to the importance of screening people with a family history of T1DM. The campaign is made of two complementary modules: Connected by T1D (for providers) and Type 1 Tested (for patients). The campaign initiation follows Provention’s announcement that the clinical module for the teplizumab BLA rolling submission has been submitted to FDA, leaving only the final CMC module to be submitted later this year. Below, FENIX provides thoughts on the campaign in the context of the FDA review of teplizumab.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

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Purchase Blast$599.00

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Provention Bio Files Teplizumab Clinical Module; ADA 2021 PDUFA Possible?

Provention Bio announced it has filed the clinical module for the teplizumab rolling BLA submission. Recall, teplizumab received Breakthrough Therapy Designation for the prevention or delay of T1DM in at-risk individuals (view previous announcement). The company continues to plan for the final CMC module to be submitted in Q4 ’20. Provention Bio previously indicated they are preparing for a 2021 launch, assuming FDA grants priority review (previous FENIX insight). Below, FENIX provides brief thoughts on teplizumab and the impending FDA review.

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

If you receive our email blasts, you already have an account.

Purchase Blast$599.00

You can read the article’s full content online after purchase.

Dexcom Publishes G6 UK Cost-Effectiveness Data and Launches G6 in Turkey; Lifescan Launches OneTouch Amazon Storefront; Daewoong Pharma Announces Ph2 Results for Enavogliflozin; Zucara Therapeutics Doses First Patient in Preventative Hypo Study

A series of diabetes-related news items have been observed: Dexcom published results from a study evaluating the cost-effectiveness of its G6 CGM in the UK and announced the launch of G6 in Turkey; Lifescan announced the launch of its OneTouch Amazon storefront; Daewoong Pharmaceutical announced the results of a Ph2 trial evaluating enavogliflozin; and Zucara Therapeutics announced the first patient has been dosed in a Ph1 trial of ZT-01 for insulin-induced hypoglycemia. Below, FENIX provides highlights and insights for the respective news items.  

About The Author

Matthew Maryniak

|
President of Fenix Group International

Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.

If you receive our email blasts, you already have an account.

Purchase Blast$599.00

You can read the article’s full content online after purchase.