Alexion’s Soliris REMS Working Well But Might Benefit From Small Changes

FDA advisory committee will weigh potential tweaks to orphan drug’s risk management plan, which is meeting informational goals regarding meningococcal infections but could be burdening prescribers with repeated assessments.

Minor tweaks may be all the adjustments needed to the Risk Evaluation and Mitigation Strategy for Alexion Pharmaceuticals Inc.’s Soliris (eculizumab), according to briefing documents released ahead of the FDA Drug Safety and Risk Management Advisory Committee’s Nov. 18 meeting.

FDA and Alexion said the current REMS with elements to assure safe use (ETASU) appears to be meeting its goals...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from United States

Kennedy Appears Ill-Informed On Major Pharma Priorities, Creating Unique Lobbying Dynamics

 

The Health and Human Services Secretary made incorrect statements about the status of key industry priorities at a recent House hearing, which actually may be a good thing for drug sponsors.

Clinical Trial Diversity Action Plan Guidance Must Return To US FDA Website, Court Says

 
• By 

HHS and its agencies violated the law by swiftly implementing “sweeping and poorly thought-through directives that ordered the bulk removal of healthcare resources,” including FDA draft guidances on diversity action plans and sex differences in clinical trials, a federal court said.

US Budget Bill Eases IRA Price Controls But Coverage Losses Will Impact Pharma

 
• By 

The legislation expected to be signed by President Trump is a mixed bag for pharmaceutical manufacturers depending on their product mix and manufacturing situation.

How Could MFN Pricing Impact Commercial Market?

 
• By 

Industry experts forecast the impact of President Trump's Most-Favored Nation drug pricing policy on the commercial insurance industry.

More from North America

How Could MFN Pricing Impact Commercial Market?

 
• By 

Industry experts forecast the impact of President Trump's Most-Favored Nation drug pricing policy on the commercial insurance industry.

COVID-19 mRNA Vaccine Labels Now Quantify Myocarditis Risk, But ACIP Wants Other Changes

 
• By 

New members of the CDC’s Advisory Committee on Immunization Practices suggested concerns beyond myocarditis, questioning whether test-negative observational studies are giving an incorrect picture of effectiveness.

Medicare’s Combo Products Negotiation Plan Conflicts With US FDA Standards, Firms Argue

 
• By 

The plan could curtail a period of pricing flexibility for newer subcutaneous versions of important oncology drugs.