The Commercial Impact of REMS Relief: Nplate/Promacta Sales Spike After Risk Management Changes

Nplate and Promacta aren’t the most important products sold by Amgen and GSK. But they are among the fastest growing in 2012—thanks to a decision by FDA to relax post-market controls at the end of 2011. The change underscores the case for a different approach to REMS in oncology, and may point the way forward for broader use of the new tools in a less intrusive way.

Promacta isn’t the type of product that usually gets mentioned by the CEO of a global pharmaceutical company during a quarterly earnings call. At less than $200 million in annual sales, Promacta (eltrombopag), approved for thrombocytopenia, is barely a rounding error in the performance of GlaxoSmithKline PLC .

But the product came up not once, but twice during GSK’s third quarter call. The first mention came during the...

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 Drug Safety

US FDA’s ADHD Drug Relabeling Advances A MAHA Priority, Reviving Data Dispute

 

Extended-release stimulants will add a new ‘Limitation of Use’ about weight loss in children under 6 years, reflecting concerns about overuse from the Make America Healthy Again commission, a concern multiple studies did not find valid.

CAR-T REMS Removal Should Boost Access, But Long-Term Follow-Up, Black Box Remain

 

The REMS removal and labeling changes should open up CAR-T treatment to many more US patients, although other regulatory hurdles and safety language that experts had wanted removed still stand.

US CDC Vaccine Committee Revives Thimerosal Debate: A Portent Of Things To Come?

 

The new Advisory Committee on Immunization Practices voted for new recommendations on the decades-old thimerosal safety issue and lays intellectual groundwork to revisit other past controversies and decisions.

ACIP Members ‘Not Easy’ To Find After Clean Sweep, US CDC Director Nominee Says

 
• By 

The CDC Advisory Committee on Immunization Practices had only seven members in place as it met for the first time since HHS Secretary Robert F. Kennedy Jr. dismissed the previous panelists. CDC Director nominee Susan Monarez said finding replacements has been difficult.

More from Pink Sheet

AI And Inertia: The Disruptors Keeping EU Regulators Awake At Night

 

Data is “the new oil,” but its use will challenge regulators, while inertia is the biggest disrupter of all for European regulators, according to European Medicines Agency chiefs past and present.

AI In Manufacturing: EU To Revamp GMP Guidance In Light Of Digital Advancements

 

Pharma firms are being encouraged to respond to a European Commission consultation on planned updates to its good manufacturing practice standards which reflect the “rapid advancement” of modern technologies, like AI and digital systems, in drug manufacturing.

China Unveils Multiple Policies To Support Innovative Drugs Throughout Life Cycle

 
• By 

China has announced a raft of new measures to encourage innovative drug development across the product life cycle, including using insurance data to differentiate new therapies and applying commercial insurance to selected novel products.