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Aubagio Approval Reflects FDA’s Evolving View On Multiple Sclerosis Drugs

 
• By Sue Sutter

Sanofi’s teriflunomide is indicated broadly for treating relapsing forms of MS. The claim marks a departure from previously approved MS drugs, in which the specific effects seen in clinical trials are described in the Indications section. FDA said the Aubagio claim more closely reflects how physicians actually use the drugs and represents a more flexible regulatory approach that enabled approval of a second, lower dose.

When it received FDA approval in September 2012, Sanofi’s oral multiple sclerosis therapy Aubagio (teriflunomide) faced a market already occupied by another oral therapy, a host of well-entrenched injectables, and several promising investigational treatments on the horizon.

Despite its late-comer status, Aubagio marked a regulatory milestone in FDA’s approval of MS treatments. It is the first disease-modifying...

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Elegy For SACHRP: US HHS Research Protection Panel Tackled Tough Pediatric Trial Questions

 
• By Bridget Silverman

The termination of the HHS Secretary’s Committee on Human Research Protections closed an important forum for discussing pediatrics and pregnancy in clinical trial design, a former SACHRP chair said.

Payment Cap Not Always Solution For Unaffordable Drugs, Maryland PDAB Director Says

 
• By Cathy Kelly

The state's Prescription Drug Affordability Board, the oldest of a growing list of the boards, chose six drugs for affordability reviews and has the authority to set a ceiling on the amount state and local government payers would reimburse for them.

Future Of US FDA’s Diversity Action Plan Guidance ‘Up In The Air’ As Statutory Deadline Looms

 
• By Sue Sutter

A 26 June deadline looms for the final guidance even though a draft guidance was removed from the agency’s website to comply with President Trump’s gender ideology executive order. The concepts underpinning the guidance are still relevant, legal experts say.

Pink Sheet Podcast: Prasad Staying Out Of Application Reviews, US FDA Proposed Budget Cuts

 
• By Derrick Gingery, Sarah Karlin-Smith, Sue Sutter, and Nielsen Hobbs

Pink Sheet reporter and editors discuss CBER Director Vinay Prasad’s expectation to stay out of routine application decisions, despite the agency’s top-down leadership approach, and the extent of proposed FDA budget cuts.

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