As FDA Decision Nears, Novartis Highlights New Analysis Of Blockbuster Hopeful Inclisiran

US Decision Expected Before 2020 Ends

Novartis has pooled cholesterol control and safety data, but will have to wait longer for cardiovascular outcomes readout.

Basel, Switzerland - 27 August, 2016: sign on the wall of a Novartis building. Novartis International AG is a Swiss pharmaceutical company based in Basel, Switzerland.
Novartis is counting on inclisuran to be a blockbuster after its $9.7bn buyout of the drug's developer, The Medicines Company

As regulators in the US and the EU prepare to pass judgement on Novartis AG’s cardiovascular drug candidate, inclisiran, the company has presented a new data analysis to back up its claims that the therapy is a potential game changer in the field and justifies the acquisition of The Medicines Company.

Inclisiran is a first-in-class small interfering RNA (siRNA) treatment for hyperlipidemia in adults, and has been studied in three large trials in patients already on statin therapy but whose

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Scrip 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 Business

Finance Watch: Funding Alternatives Become The Norm In Tough Public Markets

 
• By 

Public Company Edition: With fewer follow-on offerings, drug developers are pursuing other options. Axsome accessed up to $570m in debt, Evolus obtained $250m in a new credit facility and Abeona raised $155m from a PRV sale, but Apimeds was able to execute a small $13.5m IPO.

‘Market Developments’ Persuade Galapagos To Rethink Spin-Off

 

CEO Paul Stoffels exits early to be succeeded by Henry Gosebruch, who will now consider ‘all options’ for the Belgian firm as it tries to claw back investor confidence.

Strong Showing For Bayer’s Pharma Business In Uncertain Times

 
• By 

As CEO Anderson backs high prices for innovative drugs in Europe

Stock Watch: Stock Watch: Lilly And Novo Duke Out Q1

 
• By 

Novo Nordisk enjoyed a surprise GLP-1 agonist contracting win in the first quarter of 2025. This provided a welcome boost to its stock after it had spent the previous quarter on the back foot against rival Lilly.

More from Scrip

‘Market Developments’ Persuade Galapagos To Rethink Spin-Off

 

CEO Paul Stoffels exits early to be succeeded by Henry Gosebruch, who will now consider ‘all options’ for the Belgian firm as it tries to claw back investor confidence.

Strong Showing For Bayer’s Pharma Business In Uncertain Times

 
• By 

As CEO Anderson backs high prices for innovative drugs in Europe

Stock Watch: Stock Watch: Lilly And Novo Duke Out Q1

 
• By 

Novo Nordisk enjoyed a surprise GLP-1 agonist contracting win in the first quarter of 2025. This provided a welcome boost to its stock after it had spent the previous quarter on the back foot against rival Lilly.