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Lilly's (LLY) Ulcerative Colitis Candidate Gets CRL from FDA
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Eli Lilly (LLY - Free Report) announced that the FDA issued a complete response letter (“CRL”) to its biologics license application (“BLA”) seeking approval for interleukin 23 (“IL-23”) inhibitor drug mirikizumab in treating ulcerative colitis (“UC”).
Per management, the CRL was issued as the FDA cited issues related to the proposed manufacturing of mirikizumab. The agency did not highlight any concerns about the drug’s safety nor did it request Eli Lilly to conduct any additional studies.
Based on the responses received in the CRL, Lilly will work closely with the FDA to resolve the FDA’s concerns.
Mirikizumab was recently approved in Japan as a first-in-class treatment for adults with moderately to severely active UC. A regulatory filing for the drug in UC indication is also under review in the European Union (EU). Last month, the European Medicines Agency's (“EMA”) Committee for Medicinal Products for Human Use (“CHMP”) gave a positive opinion recommending approval of the drug
In the year so far, Eli Lilly’s stock has gained 2.5% compared with the industry’s 1.4% rise.
Image Source: Zacks Investment Research
The BLA filing for mirikizumab was based on data from the phase III LUCENT clinical program, which evaluated mirikizumab in UC. The program consisted of three late-stage studies —LUCENT-1, LUCENT-2 and LUCENT-3. Data from these studies showed that nearly all study participants treated with mirikizumab achieved clinical remission following 52 weeks of treatment.
Apart from UC, mirikizumab is also being evaluated in a late-stage study for Crohn’s disease (“CD”).
The UC market targeted by the company is highly competitive as several other pharma giants like AbbVie (ABBV - Free Report) and J&J (JNJ - Free Report) already have approved blockbuster drugs in this space.
Last month, AbbVie reported positive topline data from the phase III INSPIRE study, which evaluated the IL-23 inhibitor drug Skyrizi (risankizumab) as an induction therapy in adult patients with moderately to severely active UC. The study met all its primary and secondary endpoints. Currently, AbbVie’s Skyrizi is approved for three indications —plaque psoriasis, psoriatic arthritis (“PsA”) and CD.
Some other AbbVie’s drugs also approved for UC indication include Humira and Rinvoq. While Humira is a tumor necrosis factor (TNF) blocker, Rinvoq is a JAK inhibitor.
J&J markets its blockbuster drug Stelara,which is approved for multiple inflammatory indications, including CD, PsA and UC indications. Like mirikizumab and Skyrizi, J&J’s Stelara is also a human IL-12 and IL-23 antagonist.
This is the second CRL issued by the FDA to Eli Lilly for its pipeline candidates this year. Earlier in January, the agency rejected the company’s regulatory filing accelerated approval for Alzheimer’s drug, donanemab. Per the FDA, the CRL was issued as the study supporting the regulatory filing had limited information on patients who received at least 12 months of continued treatment on donanemab. The CRL specifically requested Lilly to provide data from at least 100 patients with at least 12 months of exposure to donanemab. Management is working closely with the agency officials to resolve their issues.
In the past 60 days, estimates for Novo Nordisk’s 2023 earnings per share have increased from $4.20 to $4.51. During the same period, the earnings estimates per share for 2024 have risen from $4.90 to $5.26. Shares of Novo Nordisk are up 23.9% in the year-to-date period.
The earnings of Novo Nordisk beat estimates in three of the last four quarters while missing the mark on one occasion. On average, the company’s earnings witnessed a surprise of 3.00%. In the last reported quarter, Novo Nordisk’searnings beat estimates by 2.47%.
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Lilly's (LLY) Ulcerative Colitis Candidate Gets CRL from FDA
Eli Lilly (LLY - Free Report) announced that the FDA issued a complete response letter (“CRL”) to its biologics license application (“BLA”) seeking approval for interleukin 23 (“IL-23”) inhibitor drug mirikizumab in treating ulcerative colitis (“UC”).
Per management, the CRL was issued as the FDA cited issues related to the proposed manufacturing of mirikizumab. The agency did not highlight any concerns about the drug’s safety nor did it request Eli Lilly to conduct any additional studies.
Based on the responses received in the CRL, Lilly will work closely with the FDA to resolve the FDA’s concerns.
Mirikizumab was recently approved in Japan as a first-in-class treatment for adults with moderately to severely active UC. A regulatory filing for the drug in UC indication is also under review in the European Union (EU). Last month, the European Medicines Agency's (“EMA”) Committee for Medicinal Products for Human Use (“CHMP”) gave a positive opinion recommending approval of the drug
In the year so far, Eli Lilly’s stock has gained 2.5% compared with the industry’s 1.4% rise.
Image Source: Zacks Investment Research
The BLA filing for mirikizumab was based on data from the phase III LUCENT clinical program, which evaluated mirikizumab in UC. The program consisted of three late-stage studies —LUCENT-1, LUCENT-2 and LUCENT-3. Data from these studies showed that nearly all study participants treated with mirikizumab achieved clinical remission following 52 weeks of treatment.
Apart from UC, mirikizumab is also being evaluated in a late-stage study for Crohn’s disease (“CD”).
The UC market targeted by the company is highly competitive as several other pharma giants like AbbVie (ABBV - Free Report) and J&J (JNJ - Free Report) already have approved blockbuster drugs in this space.
Last month, AbbVie reported positive topline data from the phase III INSPIRE study, which evaluated the IL-23 inhibitor drug Skyrizi (risankizumab) as an induction therapy in adult patients with moderately to severely active UC. The study met all its primary and secondary endpoints. Currently, AbbVie’s Skyrizi is approved for three indications —plaque psoriasis, psoriatic arthritis (“PsA”) and CD.
Some other AbbVie’s drugs also approved for UC indication include Humira and Rinvoq. While Humira is a tumor necrosis factor (TNF) blocker, Rinvoq is a JAK inhibitor.
J&J markets its blockbuster drug Stelara,which is approved for multiple inflammatory indications, including CD, PsA and UC indications. Like mirikizumab and Skyrizi, J&J’s Stelara is also a human IL-12 and IL-23 antagonist.
This is the second CRL issued by the FDA to Eli Lilly for its pipeline candidates this year. Earlier in January, the agency rejected the company’s regulatory filing accelerated approval for Alzheimer’s drug, donanemab. Per the FDA, the CRL was issued as the study supporting the regulatory filing had limited information on patients who received at least 12 months of continued treatment on donanemab. The CRL specifically requested Lilly to provide data from at least 100 patients with at least 12 months of exposure to donanemab. Management is working closely with the agency officials to resolve their issues.
Eli Lilly and Company Price
Eli Lilly and Company price | Eli Lilly and Company Quote
Zacks Rank & Stock to Consider
Eli Lilly currently carries a Zacks Rank #3 (Hold). A better-ranked stock in the overall healthcare sector is Novo Nordisk (NVO - Free Report) , which sportsa Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for Novo Nordisk’s 2023 earnings per share have increased from $4.20 to $4.51. During the same period, the earnings estimates per share for 2024 have risen from $4.90 to $5.26. Shares of Novo Nordisk are up 23.9% in the year-to-date period.
The earnings of Novo Nordisk beat estimates in three of the last four quarters while missing the mark on one occasion. On average, the company’s earnings witnessed a surprise of 3.00%. In the last reported quarter, Novo Nordisk’searnings beat estimates by 2.47%.