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A win for antisense: Isis/Genzyme score US OK for Kynamro

 
• By Donna Young

A month after a competitor's drug was approved, Genzyme and Isis Pharmaceuticals gained the US FDA's nod to market Kynamro (mipomersen sodium) to treat patients with homozygous familial hypercholesterolemia (HoFH), a rare genetic lipid disorder that causes extremely high elevations of low-density lipoprotein cholesterol (LDL-C), causing early onset of arthrosclerosis, with patients often experiencing heart attacks in their early teens, often dying before age 30.

A month after a competitor's drug was approved, Genzyme and Isis Pharmaceuticals gained the US FDA's nod to market Kynamro (mipomersen sodium) to treat patients with homozygous familial hypercholesterolemia (HoFH), a rare genetic lipid disorder that causes extremely high elevations of low-density lipoprotein cholesterol (LDL-C), causing early onset of arthrosclerosis, with patients often experiencing heart attacks in their early teens, often dying before age 30.

Investors gave shares of Carlsbad, California-based Isis, which initially developed the drug – later collaborating with Genzyme, which is responsible...

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Final Chance To Have Your Say: Take Scrip's Reader Survey This Week

 
• By Eleanor Malone

Editor’s note: This is your final call to participate in the survey to better understand our subscribers’ content and delivery needs. The deadline is 20 September.

Shape Our Content: Take The Reader Survey

 
• By Eleanor Malone

Editor’s note: We are conducting a survey to better understand our subscribers’ content and delivery needs. If there are any changes you’d like to see in the coverage topics, content format or the method in which you receive and access Scrip, or if you love it how it is, now is the time to have your voice heard.

Galapagos Expands Point-Of-Care CAR-T Study To The US

 
• By Andrew McConaghie

CEO Paul Stoffels said gaining US clearance for an IND for its novel CAR-T product was demanding, but now opens up a pathway towards a pivotal study starting in 2025.

Analysts Split On Eisai’s Chances Of Changing EU Regulator’s Mind On Leqembi

 
• By Andrew McConaghie

A final rejection of Leqembi could also spell the same fate for Lilly’s rival drug but public outcry and demand for Alzheimer’s therapies might force the regulator’s hand

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Vor Is Reborn With New CEO And Ambitious RemeGen Autoimmune Pact

 
• By Kevin Grogan

The biotech had been looking at options to survive since May.

Can Japan’s Richest Person Save Cell Therapy’s Future?

 
• By Lisa Takagi

With financial help from the founder of Uniqlo, Japan’s leading facility for induced pluripotent stem cells is aiming to automate production to slash costs and kick-start R&D in the field.

Post-BIO Podcast: Thoughts From The Frontlines

 
• By Sarah Karlin-Smith, Mandy Jackson, and Mary Jo Laffler

Scrip and Pink Sheet journalists reflect on the mood from Boston, the most important takeaways and what’s next for industry.