Big pharma Gets Breakthrough Therapy Designation for Alzheimer's Treatment From FDA

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https://www.marketwatch.com/story/e...r-alzheimer-s-treatment-from-fda-271624532290​

Eli Lilly Gets Breakthrough Therapy Designation for Alzheimer's Treatment From FDA​

Published: June 24, 2021 at 6:58 a.m. ET

 

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By Dave Sebastian


Eli Lilly & Co. said it has received breakthrough therapy designation for its Alzheimer's treatment from the U.S. Food and Drug Administration.

The designation means preliminary clinical evidence indicates the drug could show substantial improvement over available therapies on a clinically significant endpoint, and is meant to expedite the development and review of drugs for serious conditions, according to the FDA.

 

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Suddenly, big pharma getting fast track approvsl during pandemic.

 

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Lilly on Thursday said it plans to submit a biologics license application for the drug, donanemab, under the accelerated approval path later this year based on data from its Phase 2 trial. It said the safety, tolerability and efficacy of donanemab are being evaluated in an ongoing Phase 3 study.


Write to Dave Sebastian at [email protected]

 

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https://www.biospace.com/article/li...-therapy-designation-for-alzheimer-s-disease/

Eli Lilly Guns for Alzheimer's Drug Approval with FDA's Breakthrough Therapy Designation​

Published: Jun 24, 2021By Brandon May

 

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Eli Lilly’s investigational antibody therapy, donanemab, has been granted Breakthrough Therapy designation by the U.S. Food and Drug Administration for Alzheimer’s disease (AD). The company said it will file a marketing application later this year for the drug under the FDA’s accelerated approval pathway.

The agency was granted Breakthrough Therapy designation for donanemab based on data from Eli Lilly’s Phase II TRAILBLAZER-ALZ study. This randomized, multi-center trial evaluated the safety and efficacy of the antibody agent in patients with early and symptomatic AD.

A total of 272 patients in the TRAILBLAZER-ALZ trial were randomly assigned to either donanemab or placebo. Researchers compared the two arms in regard to the change in the Integrated Alzheimer's Disease Rating Scale (iADRS) from baseline to 76 weeks.

 

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The findings from this study, which were presented at the 15thth International Conference on Alzheimer’s and Parkinson’s Diseases 2021 and simultaneously published in the New England Journal of Medicine, showed donanemab significantly slowed the decline of the iADRS.

Despite these promising results, however, mixed findings for the secondary endpoints muddied the clarity on the therapy’s full-reaching benefits. For instance, patients in the donanemab arm demonstrated numerically better performance on several dementia rating scales compared with those in the placebo group, but the differences between the two arms weren’t statistically significant in all cases.

According to a statement made by Eli Lilly, the company said it plans to submit a biologics license application (BLA) for the therapy under the accelerated approval based on the TRAILBLAZER-ALZ findings. The company also stated it is currently evaluating donanemab’s safety, tolerability and efficacy in the Phase III TRAILBLAZER-ALZ 2 trial (NCT04437511).

 

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Eli Lilly faces competition from Biogen’s recently approved AD drug Aduhelm (aducanumab), another antibody that is also aimed at targeting amyloid. Other up-and-coming contenders include Eisai and Biogen’s lecanemab as well as Roche's gantenerumab.

The recent approval of Biogen’s Aduhelm was based on clinical evidence showing the drug cleared plaque-forming beta-amyloid protein clumps in the brain of a patient with AD. However, the clinical evidence didn’t necessarily show whether the drug could slow progression of disease after clearing these plaques.

Several controversies have clouded the Aduhelm approval, including the whopping price tag of $56,000 a year. Given the price point and the lack of robust clinical data showing Aduhelm slows AD progression, three members of the FDA advisory panel resigned from their posts to protect the approval.

A watchdog organization recently called for more FDA officials to resign in an eight-page letter to the U.S. Department of Health and Human Services Secretary Xavier Becerra. The organization, Public Citizen, said acting Commissioner Janet Woodcock and other agency officials involved in the aducanumab approval should resign from their posts immediately.

 

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Additionally, the organization stated Patrizia Cavazzoni, the Center for Drug Evaluation and Research Director, and Billy Dunn, the CDER’s Office of Neuroscience Director, should also resign from their positions following the approval decision. Public Citizen also noted that the per-year price tag for the therapy threatens Medicare’s financial stability.

Public Citizen said in its letter, “The primary beneficiaries of the agency’s action are Biogen and its shareholders, who undoubtedly are ecstatic about their soon-to-be-reaped windfall profits from sales of the company’s exorbitantly priced but ineffective drug.”

 

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https://www.fiercebiotech.com/biote...roval-alzheimer-s-drug-after-aduhelm-ok-opens

Lilly to file for accelerated FDA approval of Alzheimer's drug after Aduhelm OK opens the floodgates​

by Nick Paul Taylor|
Jun 24, 2021 8:15am

Investors predicted that Eli Lilly would be the real winner from the FDA's approval of Biogen's Aduhelm, and here's your proof.

Lilly plans to file for accelerated approval of its Alzheimer’s disease prospect donanemab later this year, a therapy the company once thought would need boat loads more data to get over the regulatory finish line.

The planned filing on the strength of phase 2 data comes hot on the heels of the FDA’s decision to grant accelerated approval to Biogen’s Aduhelm.

Lilly CFO Anat Ashkenazi downplayed the prospect of filing for approval on the basis of the midphase trial late last month. Talking at an investor conference, Ashkenazi said Lilly expected to need two controlled studies for an approval, adding that the traditional requirement “should be the case, because then you have more data and ability to see segment information across patients, less variability, et cetera.”

Two weeks after Ashkenazi made those comments, the FDA reset the evidence bar for getting drugs against Alzheimer’s to market by granting accelerated approval to Biogen’s Aduhelm on the strength of a surrogate endpoint. Lilly’s rapid U-turn suggests the FDA may have opened the floodgates to new Alzheimer’s drugs.

Lilly is running a phase 3 clinical trial of donanemab but, with the FDA opening the door to approval of Alzheimer’s treatments without the usual proof of clinical efficacy, the company no longer sees a need to wait for the data before trying to get the product to market. Lilly disclosed news of its plan as part of a statement about the FDA awarding breakthrough-therapy status to donanemab.

 

[ginfreely]

https://www.fiercebiotech.com/biote...roval-alzheimer-s-drug-after-aduhelm-ok-opens

Lilly to file for accelerated FDA approval of Alzheimer's drug after Aduhelm OK opens the floodgates​

by Nick Paul Taylor|
Jun 24, 2021 8:15am

Investors predicted that Eli Lilly would be the real winner from the FDA's approval of Biogen's Aduhelm, and here's your proof.

Lilly plans to file for accelerated approval of its Alzheimer’s disease prospect donanemab later this year, a therapy the company once thought would need boat loads more data to get over the regulatory finish line.

The planned filing on the strength of phase 2 data comes hot on the heels of the FDA’s decision to grant accelerated approval to Biogen’s Aduhelm.

Lilly CFO Anat Ashkenazi downplayed the prospect of filing for approval on the basis of the midphase trial late last month. Talking at an investor conference, Ashkenazi said Lilly expected to need two controlled studies for an approval, adding that the traditional requirement “should be the case, because then you have more data and ability to see segment information across patients, less variability, et cetera.”

Two weeks after Ashkenazi made those comments, the FDA reset the evidence bar for getting drugs against Alzheimer’s to market by granting accelerated approval to Biogen’s Aduhelm on the strength of a surrogate endpoint. Lilly’s rapid U-turn suggests the FDA may have opened the floodgates to new Alzheimer’s drugs.

Lilly is running a phase 3 clinical trial of donanemab but, with the FDA opening the door to approval of Alzheimer’s treatments without the usual proof of clinical efficacy, the company no longer sees a need to wait for the data before trying to get the product to market. Lilly disclosed news of its plan as part of a statement about the FDA awarding breakthrough-therapy status to donanemab.

Wow I am impressed with angmoh the best big pharma so agile. No wonder the best.