Sanofi and Provention Bio partner to support potential launch of drug to delay type 1

Olivier Bogillot, Head of US General Medicines at Sanofi, said: “We are delighted by the prospect of supporting Provention Bio in bringing to the US what could become the first-in-class therapy to change the course of type 1 diabetes. If approved, Sanofi US will leverage its existing world-class capabilities in diabetes care to enhance efforts in both patient and healthcare provider access. We are prepared to tap into all of our internal expertise to support the successful launch of this innovative therapy.”

While Ashleigh Palmer, Co-Founder and Chief Executive Officer at Provention Bio, added: “We look forward to working with our colleagues at Sanofi as we prepare to deliver, if approved, the first-ever disease-modifying therapy for T1D.”

What is teplizumab?

Teplizumab is a promising immunotherapy drug that can protect insulin-producing beta cells from the immune attack that causes type 1 diabetes. It does this by targeting the aggressive immune cells to disarm and kill them.

In doing so, the exciting new drug led to an average three-year delay in the onset of type 1 for people at most risk. This means giving a pre-diabetes patient an extra three years with a functioning pancreas. This remarkable effect is achieved after just 14 days of injections of teplizumab.

Awaiting approval in the US

Teplizumab is currently under review by the US Food and Drug Administration (FDA) after Provention Bio submitted more evidence in favour of its effectiveness. Sanofi has pledged to invest further in Provention Bio if the FDA does approve teplizumab.

The FDA is expected to announce its decision whether to approve the use of teplizumab in the US later in November.

How will this impact the UK?

If the FDA approves teplizumab it will likely influence the decision of international agencies like the Medicines and Healthcare products Regulatory Agency (MHRA), which authorises drugs in the UK.

In summer 2021, teplizimuab was awarded an Innovation Passport by the MHRA. This means that the MHRA has been working closely with Provention Bio to drive teplizimuab towards becoming a licensed treatment in the UK to delay type 1 in those at most risk.

Pivotal role by JDRF

The Innovation Passport and the fast-track it provides was made possible by robust evidence provided by JDRF-funded clinical trials. We are now funding clinical trials as part of the Type 1 Diabetes UK Immunotherapy Consortium to see if teplizumab can also slow the disease progression in people who already have type 1.