We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies, revised Privacy Policy and Terms of Service.
You are being directed to ZacksTrade, a division of LBMZ Securities and licensed broker-dealer. ZacksTrade and Zacks.com are separate companies. The web link between the two companies is not a solicitation or offer to invest in a particular security or type of security. ZacksTrade does not endorse or adopt any particular investment strategy, any analyst opinion/rating/report or any approach to evaluating individual securities.
If you wish to go to ZacksTrade, click OK. If you do not, click Cancel.
FDA Sets the Stage for Earlier-Stage Alzheimer's Treatments
Read MoreHide Full Article
The FDA has proposed new guidelines, which are aimed at lowering the clinical study goals of Alzheimer’s disease drugs for treating earlier-stage patients who have not yet displayed functional disability or clinical abnormality. This strategy, part of FDA’s ongoing efforts to expand access to safe and effective treatment options for many serious conditions, suggests that the agency may be open to an accelerated approval process for such drugs.
FDA’s proposed guidelines came in a week when major disappointments in the field were announced by companies developing drugs to treat this deadly brain disease.
Earlier this week, Merck (MRK - Free Report) announced that it is discontinuing another study evaluating verubecestat for the treatment of prodromal Alzheimer’s disease as its success was unlikely.
Biogen (BIIB - Free Report) also announced that it has decided to increase the number of patients (enrolment) in studies being conducted on its crucial Alzheimer’s disease candidate, aducanumab, which raised concerns regarding the chances of success of the treatment. In December 2017, Biogen’s Alzheimer’s disease study on another candidate, BAN2401 failed to show early positive results, which raised investor concern about the candidate’s chances of success.
The Alzheimer’s disease market has attracted a lot of attention from several companies. However, the successful development of therapies for the treatment of Alzheimer’s disease is challenging.
This may be somewhat because the underlying causes of severe neurological ailments like Alzheimer’s may not be as clear as diseases like cancer. Also, Alzheimer’s progress may go unnoticed for years. By the time, the symptoms of the ailment become evident, significant function may already be lost, which makes developing drugs to treat this disease difficult.
We note that several companies have failed in this regard.
Last month, Pfizer (PFE - Free Report) reportedly announced the termination of its R&D efforts in the Alzheimer’s and Parkinson’s disease areas, which will result in about 300 layoffs. Long back, Pfizer shelved its late-stage Alzheimer’s candidate, bapineuzumab IV after it failed two phase III studies.
In November 2016, Lilly’s (LLY - Free Report) anti-amyloid candidate solanezumab failed to meet the primary endpoint in a late-stage AD study. Lilly decided to drop the development of solanezumab. Lilly also suffered a major setback in August 2010, when it had to halt the development of another phase III Alzheimer’s candidate, semagacestat.
The Alzheimer’s disease market represents huge commercial potential and a successfully developed product could generate billions of dollars in sales once launched.
FDA’s latest effort may reinvigorate research efforts for Alzheimer’s drugs after repeated failures.
Wall Street’s Next Amazon
Zacks EVP Kevin Matras believes this familiar stock has only just begun its climb to become one of the greatest investments of all time. It’s a once-in-a-generation opportunity to invest in pure genius.
Image: Bigstock
FDA Sets the Stage for Earlier-Stage Alzheimer's Treatments
The FDA has proposed new guidelines, which are aimed at lowering the clinical study goals of Alzheimer’s disease drugs for treating earlier-stage patients who have not yet displayed functional disability or clinical abnormality. This strategy, part of FDA’s ongoing efforts to expand access to safe and effective treatment options for many serious conditions, suggests that the agency may be open to an accelerated approval process for such drugs.
FDA’s proposed guidelines came in a week when major disappointments in the field were announced by companies developing drugs to treat this deadly brain disease.
Earlier this week, Merck (MRK - Free Report) announced that it is discontinuing another study evaluating verubecestat for the treatment of prodromal Alzheimer’s disease as its success was unlikely.
Biogen (BIIB - Free Report) also announced that it has decided to increase the number of patients (enrolment) in studies being conducted on its crucial Alzheimer’s disease candidate, aducanumab, which raised concerns regarding the chances of success of the treatment. In December 2017, Biogen’s Alzheimer’s disease study on another candidate, BAN2401 failed to show early positive results, which raised investor concern about the candidate’s chances of success.
The Alzheimer’s disease market has attracted a lot of attention from several companies. However, the successful development of therapies for the treatment of Alzheimer’s disease is challenging.
This may be somewhat because the underlying causes of severe neurological ailments like Alzheimer’s may not be as clear as diseases like cancer. Also, Alzheimer’s progress may go unnoticed for years. By the time, the symptoms of the ailment become evident, significant function may already be lost, which makes developing drugs to treat this disease difficult.
We note that several companies have failed in this regard.
Last month, Pfizer (PFE - Free Report) reportedly announced the termination of its R&D efforts in the Alzheimer’s and Parkinson’s disease areas, which will result in about 300 layoffs. Long back, Pfizer shelved its late-stage Alzheimer’s candidate, bapineuzumab IV after it failed two phase III studies.
In November 2016, Lilly’s (LLY - Free Report) anti-amyloid candidate solanezumab failed to meet the primary endpoint in a late-stage AD study. Lilly decided to drop the development of solanezumab. Lilly also suffered a major setback in August 2010, when it had to halt the development of another phase III Alzheimer’s candidate, semagacestat.
The Alzheimer’s disease market represents huge commercial potential and a successfully developed product could generate billions of dollars in sales once launched.
FDA’s latest effort may reinvigorate research efforts for Alzheimer’s drugs after repeated failures.
Wall Street’s Next Amazon
Zacks EVP Kevin Matras believes this familiar stock has only just begun its climb to become one of the greatest investments of all time. It’s a once-in-a-generation opportunity to invest in pure genius.
Click for details >>