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FDA panel backs Provention Bio’s type 1 prevention drug teplizumab

Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) narrowly voted in favour of supporting approval of the drug

A US Food and Drug Administration (FDA) panel has voted in favour of Provention Bio’s type 1 diabetes prevention drug teplizumab, setting it up for a potential approval in July.

The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) voted 10-7 in favour of the benefits of teplizumab outweighing its risks to support approval of the drug to delay type 1 diabetes.

The EMDAC based its recommendation on data from the phase 2 TN-10 study, which randomly assigned 76 participants aged eight to 45 years old to receive a 14-day treatment course of teplizumab or placebo.

In this study, teplizumab demonstrated a significant delay in the onset and diagnosis of the chronic condition. Compared to placebo, children and adults who were considered high-risk of developing type 1 diabetes saw it delayed by a median of two years.

However, some members of the EMDAC took issue with the size of the study, noting that the drug was actually tested in only 44 participants.

On top of that, Provention Bio also submitted safety data for teplizumab in another indication, with the panelists commenting this could not be used to make a good comparison.

Some EMDAC members also raised concerns regarding the higher rate of serious adverse events among teplizumab-treated patients, compared to placebo – 16% and 3%, respectively.

Nevertheless, the Provention Bio’s chief executive oficer Ashleigh Palmer thanked the EMDAC for its “thorough discussion and deliberations resulting in today's favourable vote”.

She added: “We know the [type 1 diabetes] community and at-risk patients and their families in particular are waiting urgently for access to clinical advancements to address their significant medical needs. We remain committed to working closely with the FDA to hopefully secure approval of teplizumab and potentially bring the first disease-modifying therapy in T1D to at-risk patients as soon as possible."

The prescription drug user fee act (PDUFA) action date for a final FDA decision on the biologics license application (BLA) for teplizumab is due on 2 July 2021.

However, the company added that previously disclosed issues with the pharmacokinetic comparability for the drug – which were not discussed during the EMDAC meeting – are ‘likely’ to result in a delay to the potential BLA approval timelines.

Article by
Lucy Parsons

28th May 2021

From: Regulatory



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