360° Coverage : FDA Sprinkles Some Rain On the PCSK9 Inhibitor Parade

2 Updates

FDA Sprinkles Some Rain On the PCSK9 Inhibitor Parade

Mar 7 2014, 5:58pm CST | by

In the last few years the PCSK9 inhibitors have been one of the few bright lights in an otherwise dismal field of new cardiovascular drugs. Now the FDA is raising questions that could dramatically...

Filed under: news

 
 
 

25 weeks ago

FDA Sprinkles Some Rain On the PCSK9 Inhibitor Parade

Mar 7 2014, 5:58pm CST | by

In the last few years the PCSK9 inhibitors have been one of the few bright lights in an otherwise dismal field of new cardiovascular drugs. Now the FDA is raising questions that could dramatically slow down the progress of these new cholesterol-lowering drugs.

Last month Regeneron disclosed that it had been “advised by the FDA that it has become aware of neurocognitive adverse events in the PCSK9 inhibitor class. The FDA requested that Regeneron and its partner, Sanofi, “make an assessment of potential neurocognitive adverse events across the global development program” of their PCSK9 inhibitor, alirocumab. Regeneron and Sanofi said they were “not aware of any neurocognitive adverse event signal relating to alirocumab” but warned that “if this or another adverse event signal is detected, the further development of alirocumab may be delayed or fail, or its commercial value diminished.”

No one remarked on the statement last month when it was buried in the Regeneron annual report. But when the same statement was discovered today in Sanofi’s annual report, a Twitter storm ensued, and the companies’ stocks, as well as Amgen’s (which is also developing a PCSK9 inhibitor) took significant hits.

Reporters and analysts asked around but found no obvious source for the FDA’s concerns. Regeneron, Sanofi, Amgen, and Pfizer all denied finding any signal for neurocognitive adverse events in their data.

Short of the remote possibility that neurocognitive adverse events could scuttle the entire class of drugs, a more likely problem is that these concerns could result in serious delays in the approval of these drugs, which many thought were on a smooth path to approval. Most ominously, the companies said that the FDA asked “about the feasibility of incorporating neurocognitive testing into at least a subset of patients” in clinical trials. The conventional wisdom has been that the PCSK9 inhibitors will be able to gain approval before the completion of outcome studies. The concern now is that the FDA will insist that these studies be completed before the drugs can be approved.

Source: Forbes Business

 
Update
2

4 days ago

Khazanah throws MAS RM6b lifeline

Aug 29 2014 5:01pm CDT | Source: Business Times Singapore

August 30, 2014 1:15 AMKHAZANAH Nasional will inject RM6 billion (SS$2.4 billion) over three years to resuscitate loss-making Malaysia Airlines (MAS) under a recovery plan that includes even an Act of Parliament. Other key moves are migrating its operations, assets and liabilities to a new company (NewCo) and slashing the workf ...
Source: Business Times Singapore   Full article at: Business Times Singapore
 

 
Update
1

5 days ago

MAS posts loss of RM307m for Q2

Aug 28 2014 5:00pm CDT | Source: Business Times Singapore

August 29, 2014 1:13 AMMALAYSIA Airlines (MAS) registered a loss of RM307 million (S$122 million) for the second quarter to end-June, but warned of worse to come in the second half when the "full financial impact of the double tragedies of MH370 and MH17" hi ...
Source: Business Times Singapore   Full article at: Business Times Singapore
 

 

Don't miss ...

 

<a href="/latest_stories/all/all/30" rel="author">Forbes</a>
Forbes is among the most trusted resources for the world's business and investment leaders, providing them the uncompromising commentary, concise analysis, relevant tools and real-time reporting they need to succeed at work, profit from investing and have fun with the rewards of winning.

 

blog comments powered by Disqus

Latest stories

No link between Ebola outbreaks in West Africa, DRC : WHO
Geneva, Sep 3 (IANS) The World Health Organisation Tuesday said the outbreak in Democratic Republic of Congo (DRC) is "a distinct and independent event", with no relationship to the epidemic in West Africa.
 
 
US CDC calls for global response against Ebola
Washington, Sep 3 (IANS/EFE) The head of US Centers for Disease Control and Prevention (CDC) Tuesday warned of the risk that the Ebola outbreak could get out of control without a greater worldwide response.
 
 
US doctor tests positive for Ebola in Liberia
Washington, Sep 3 (IANS) An American missionary doctor working in Liberia has tested positive for the Ebola virus, his organisation SIM USA announced Tuesday.
 
 
IS video shows beheading of second US journalist
Washington, Sep 2 (IANS) Days after the beheading of American photojournalist James Foley, Sunni militant group Islamic State (IS) has posted a video showing the beheading of another kidnapped American journalist Steven Sotloff, CNN reported.
 
 
 

Latest from the Network

Miltos Yerolemou joins 'Star Wars Episode VII' cast
Los Angeles, Sep 3 (IANS) Miltos Yerolemou, who was seen as swordsman Syrio Forel in TV show "Game of Thrones", joins the cast of "Star Wars Episode VII". Harrison Ford, Carrie Fisher and Mark Hamill return as Han...
Read more on Celebrity Balla
 
No link between Ebola outbreaks in West Africa, DRC : WHO
Geneva, Sep 3 (IANS) The World Health Organisation Tuesday said the outbreak in Democratic Republic of Congo (DRC) is "a distinct and independent event", with no relationship to the epidemic in West Africa. Based on...
Read more on Business Balla
 
US warplanes drop leaflets on Iraqi city
Baghdad, Sep 3 (IANS/EFE) US warplanes Tuesday dropped thousands of leaflets on the northern Iraqi city of Mosul, urging residents to keep clear of places occupied by the Islamic State (IS) extremist group that overran...
Read more on Politics Balla
 
US CDC calls for global response against Ebola
Washington, Sep 3 (IANS/EFE) The head of US Centers for Disease Control and Prevention (CDC) Tuesday warned of the risk that the Ebola outbreak could get out of control without a greater worldwide response. "This is...
Read more on Business Balla
 
Don't have a perfect body: Charlize Theron
Los Angeles, Sep 3 (IANS) Actress Charlize Theron says she doesn't have an ideal figure, but is happy with the way her body looks. The actress features on the cover of Modern Luxury's September 2014 issue and looks...
Read more on Celebrity Balla
 
Kate Hudson is 'basically married'
Kate Hudson says she and Matthew Bellamy are ''basically married.'' The 35-year-old actress, who has son Bingham, three, with the Muse frontman, 36, admits they're in no rush to plan to a wedding and she rarely wears...
Read more on Celebrity Balla
 
Cee Lo Green's reality show is axed
Cee Lo Green's reality TV series has been axed. TBS announced on Tuesday (09.02.14) that the 'Forget You' hitmaker's show, 'The Good Life,' which focused on his attempts to juggle his careers as a producer, recording...
Read more on Celebrity Balla
 
Chris Martin spends weekend with Gwyneth Paltrow
Chris Martin and Gwyneth Paltrow spent the weekend together in the Hamptons. The former couple, who announced they were ''consciously uncoupling'' in late March after 10 years of marriage, reunited at their home in the...
Read more on Celebrity Balla
 
Mali mine blast kills four UN peacekeepers
Bamako, Sep 3 (IANS) Four United Nations peacekeepers were killed and 15 others injured after their vehicle hit a landmine in Mali Tuesday, security sources said. The UN vehicle was hit by a landmine when the...
Read more on Politics Balla
 
Kate, Cara new faces of Burberry's latest fragrance
London, Sep 3 (IANS) Supermodels Kate Moss and Cara Delevingne have been roped in as the new faces of Burberry's latest fragrance. The models are pictured in the campaign for the label's latest scent My Burberry, shot...
Read more on Celebrity Balla