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This week, the FDA rejected Eli Lilly’s (LLY - Free Report) regulatory application seeking accelerated approval of a new Alzheimer’s drug, donanemab, saying it requires more data. Moderna’s (MRNA - Free Report) pivotal phase III study on its mRNA-based respiratory syncytial virus (RSV) vaccine in older adults, achieved the primary efficacy endpoints. J&J (JNJ - Free Report) discontinued a phase III study on its HIV vaccine candidate.
Recap of the Week’s Most Important Stories
FDA Gives CRL to Lilly’s Donanemab BLA: The FDA issued a complete response letter (CRL) to Eli Lilly’s biologics license application (BLA) seeking accelerated approval for donanemab for the treatment of early symptomatic Alzheimer's disease. The BLA was based on data from the phase II TRAILBLAZER-ALZ study, which showed that donanemab led to amyloid plaque reduction
The FDA rejected the BLA as it believes the accelerated approval submission includes data for only a limited number of patients with 12-month drug exposure. The FDA has asked Lilly to include data from at least 100 patients who received a minimum of 12 months of continued treatment with donanemab.
Despite the CRL, Lilly still expects top-line data readout from the confirmatory phase III TRAILBLAZER-ALZ 2 study by mid-2023, which, if positive, will form the basis of its application for traditional regulatory approval. However, the CRL will probably delay the potential launch of the candidate by several months.
J&J Ends HIV Vaccine Study: J&J said that it is discontinuing a phase III study on its investigational HIV vaccine regimen on the recommendation of the study’s independent Data and Safety Monitoring Board (DSMB). In an independent data review, the DSMB determined that the investigational HIV vaccine regimen was not effective in preventing HIV infection among study participants and the study is not expected to meet its primary endpoint. In August last year, J&J had discontinued another phase IIb Imbokodo HIV vaccine study in a population of young women in sub-Saharan Africa as the candidate could not provide sufficient protection against HIV infection.
Moderna’s RSV Vaccine Meets Goal in Study in Older Adults: Moderna’s investigational mRNA vaccine, mRNA-1345, targeting RSV met the primary efficacy endpoints in a phase III study, ConquerRSV, in older adults. The vaccine demonstrated an efficacy of 83.7% against RSV-associated lower respiratory tract disease (RSV-LRTD) as defined by two or more symptoms in older adults. Moderna plans to file regulatory applications seeking approval for mRNA-1345 in the first half of 2023. The company is also evaluating mRNA-1345 in an early-stage study in pediatric populations.
The NYSE ARCA Pharmaceutical Index declined 0.68% in the last five trading sessions.
Image: Bigstock
Pharma Stock Roundup: LLY's Donanemab Gets FDA's CRL, MRNA RSV Jab Study Succeeds
This week, the FDA rejected Eli Lilly’s (LLY - Free Report) regulatory application seeking accelerated approval of a new Alzheimer’s drug, donanemab, saying it requires more data. Moderna’s (MRNA - Free Report) pivotal phase III study on its mRNA-based respiratory syncytial virus (RSV) vaccine in older adults, achieved the primary efficacy endpoints. J&J (JNJ - Free Report) discontinued a phase III study on its HIV vaccine candidate.
Recap of the Week’s Most Important Stories
FDA Gives CRL to Lilly’s Donanemab BLA: The FDA issued a complete response letter (CRL) to Eli Lilly’s biologics license application (BLA) seeking accelerated approval for donanemab for the treatment of early symptomatic Alzheimer's disease. The BLA was based on data from the phase II TRAILBLAZER-ALZ study, which showed that donanemab led to amyloid plaque reduction
The FDA rejected the BLA as it believes the accelerated approval submission includes data for only a limited number of patients with 12-month drug exposure. The FDA has asked Lilly to include data from at least 100 patients who received a minimum of 12 months of continued treatment with donanemab.
Despite the CRL, Lilly still expects top-line data readout from the confirmatory phase III TRAILBLAZER-ALZ 2 study by mid-2023, which, if positive, will form the basis of its application for traditional regulatory approval. However, the CRL will probably delay the potential launch of the candidate by several months.
J&J Ends HIV Vaccine Study: J&J said that it is discontinuing a phase III study on its investigational HIV vaccine regimen on the recommendation of the study’s independent Data and Safety Monitoring Board (DSMB). In an independent data review, the DSMB determined that the investigational HIV vaccine regimen was not effective in preventing HIV infection among study participants and the study is not expected to meet its primary endpoint. In August last year, J&J had discontinued another phase IIb Imbokodo HIV vaccine study in a population of young women in sub-Saharan Africa as the candidate could not provide sufficient protection against HIV infection.
Moderna’s RSV Vaccine Meets Goal in Study in Older Adults: Moderna’s investigational mRNA vaccine, mRNA-1345, targeting RSV met the primary efficacy endpoints in a phase III study, ConquerRSV, in older adults. The vaccine demonstrated an efficacy of 83.7% against RSV-associated lower respiratory tract disease (RSV-LRTD) as defined by two or more symptoms in older adults. Moderna plans to file regulatory applications seeking approval for mRNA-1345 in the first half of 2023. The company is also evaluating mRNA-1345 in an early-stage study in pediatric populations.
The NYSE ARCA Pharmaceutical Index declined 0.68% in the last five trading sessions.
Large Cap Pharmaceuticals Industry 5YR % Return
Large Cap Pharmaceuticals Industry 5YR % Return
Here’s how the eight major stocks performed in the last five trading sessions.
Image Source: Zacks Investment Research
In the last five trading sessions, Roche rose the most (3.1%), while AbbVie declined the most (5.4%).
In the past six months, Merck has risen the most (21.9%), while Pfizer declined the most (12.1%).
(See the last pharma stock roundup here: FDA Gives Nod to RHHBY’s Lunsumio, Accepts PFE Vaccine BLA)
What's Next in the Pharma World?
Watch out for regular pipeline and regulatory updates next week.