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Pharma Stock Roundup: SNY's COPD Study Meets Goal, ABBV Parkinson's Drug Gets CRL
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This week, Sanofi (SNY - Free Report) and partner Regeneron’s (REGN - Free Report) blockbuster medicine, Dupixent succeeded in a pivotal study for yet another new indication, chronic obstructive pulmonary disease (COPD).The FDA declined to approve AbbVie’s (ABBV - Free Report) Parkinson’s disease (PD) therapy, ABBV-951. Roche (RHHBY - Free Report) entered into a deal with Eli Lilly (LLY - Free Report) for the development of its blood test for early diagnosis of Alzheimer’s disease.
Recap of the Week’s Most Important Stories
Sanofi’s Dupixent Meets Primary Endpoint in COPD study: The pivotal phase III study, BOREAS, which evaluated Sanofi/Regeneron’s Dupixent for treating COPD, met both its primary and secondary endpoints. Data from the BOREAS study demonstrated that Dupixent led to a clinically meaningful and statistically significant reduction (30%) in exacerbations compared to placebo. In fact, treatment with the drug also led to significant improvement in lung function, quality of life and respiratory symptoms.
Dupixent is currently approved in the United States and EU for five type II inflammatory diseases, namely severe chronic rhinosinusitis with nasal polyposis, severe asthma, moderate-to-severe atopic dermatitis, eosinophilic esophagitis and prurigo nodularis. The promising data from the COPD study opens up a new avenue for growth for this already highly successful medicine.
Sanofi and Regeneron are also evaluating Dupixent in the COPD indication in an ongoing second replicate phase III study (NOTUS). Data from the same is expected next year, following which the companies plan to file for approval.
The European Commission approved Dupixent for treating children six months to five years of age with severe atopic dermatitis, also called eczema, who are candidates for systemic therapy. Dupixent was approved by the FDA for atopic dermatitis in children in this age group in June 2022. In Europe, approximately 80,000 infants and young children have uncontrolled severe atopic dermatitis, which signifies the drug’s significant unmet need for kids under 5 years.
FDA Gives CRL to AbbVie NDA for Parkinson’s Candidate: The FDA issued a complete response letter (CRL) to AbbVie’s new drug application (“NDA”) seeking approval for ABBV-951 for the treatment of motor fluctuations in patients with advanced PD. ABBV-951 is a solution of carbidopa and levodopa prodrugs, which are the standard of care for PD patients. ABBV-951 has been designed to offer continuous subcutaneous delivery of CD/LD prodrugs through a pump device and offer a better patient experience. In the CRL, the FDA has asked for some extra information about the pump device used to administer the medicine. The FDA has not requested any additional efficacy/safety studies.
AbbVie’s phase II study evaluating Rinvoq (upadacitinib) for patients with moderately to severely active systemic lupus erythematosus (SLE) met the primary endpoint in the 30 mg group. The primary endpoint of the study was achieving SLE Responder Index (SRI-4) with a steroid dose less than or equal to 10 mg prednisone equivalent once daily at week 24. Based on the phase II positive data, AbbVie is advancing upadacitinib to phase III development for SLE.
AbbVie also announced positive data from a phase III induction study evaluating Skyrizi (risankizumab) to treat moderately to severely active ulcerative colitis. The data showed that a significantly higher proportion of patients, 20.3% treated with risankizumab achieved the primary endpoint of clinical remission compared to 6.2% of patients on placebo at week 12. The study also met all secondary endpoints, including clinical, endoscopic and histologic outcomes. Skyrizi is presently approved for Crohn's disease, psoriatic arthritis and psoriasis.
Roche & Lilly’s Alzheimer’s Collaboration: Roche announced a collaboration with Lilly for the development of Elecsys Amyloid Plasma Panel (EAPP), its blood test for earlier diagnosis of Alzheimer’s disease. The FDA had granted Breakthrough Device Designation to EAPP in July last year. Lilly has donanemab and remternetug in its Alzheimer’s pipeline. In January, the FDA issued a CRL to Lilly’s biologics license application for donanemab for treating early symptomatic Alzheimer's disease.
The NYSE ARCA Pharmaceutical Index declined 1.8% in the last five trading sessions.
Image: Bigstock
Pharma Stock Roundup: SNY's COPD Study Meets Goal, ABBV Parkinson's Drug Gets CRL
This week, Sanofi (SNY - Free Report) and partner Regeneron’s (REGN - Free Report) blockbuster medicine, Dupixent succeeded in a pivotal study for yet another new indication, chronic obstructive pulmonary disease (COPD).The FDA declined to approve AbbVie’s (ABBV - Free Report) Parkinson’s disease (PD) therapy, ABBV-951. Roche (RHHBY - Free Report) entered into a deal with Eli Lilly (LLY - Free Report) for the development of its blood test for early diagnosis of Alzheimer’s disease.
Recap of the Week’s Most Important Stories
Sanofi’s Dupixent Meets Primary Endpoint in COPD study: The pivotal phase III study, BOREAS, which evaluated Sanofi/Regeneron’s Dupixent for treating COPD, met both its primary and secondary endpoints. Data from the BOREAS study demonstrated that Dupixent led to a clinically meaningful and statistically significant reduction (30%) in exacerbations compared to placebo. In fact, treatment with the drug also led to significant improvement in lung function, quality of life and respiratory symptoms.
Dupixent is currently approved in the United States and EU for five type II inflammatory diseases, namely severe chronic rhinosinusitis with nasal polyposis, severe asthma, moderate-to-severe atopic dermatitis, eosinophilic esophagitis and prurigo nodularis. The promising data from the COPD study opens up a new avenue for growth for this already highly successful medicine.
Sanofi and Regeneron are also evaluating Dupixent in the COPD indication in an ongoing second replicate phase III study (NOTUS). Data from the same is expected next year, following which the companies plan to file for approval.
The European Commission approved Dupixent for treating children six months to five years of age with severe atopic dermatitis, also called eczema, who are candidates for systemic therapy. Dupixent was approved by the FDA for atopic dermatitis in children in this age group in June 2022. In Europe, approximately 80,000 infants and young children have uncontrolled severe atopic dermatitis, which signifies the drug’s significant unmet need for kids under 5 years.
FDA Gives CRL to AbbVie NDA for Parkinson’s Candidate: The FDA issued a complete response letter (CRL) to AbbVie’s new drug application (“NDA”) seeking approval for ABBV-951 for the treatment of motor fluctuations in patients with advanced PD. ABBV-951 is a solution of carbidopa and levodopa prodrugs, which are the standard of care for PD patients. ABBV-951 has been designed to offer continuous subcutaneous delivery of CD/LD prodrugs through a pump device and offer a better patient experience. In the CRL, the FDA has asked for some extra information about the pump device used to administer the medicine. The FDA has not requested any additional efficacy/safety studies.
AbbVie’s phase II study evaluating Rinvoq (upadacitinib) for patients with moderately to severely active systemic lupus erythematosus (SLE) met the primary endpoint in the 30 mg group. The primary endpoint of the study was achieving SLE Responder Index (SRI-4) with a steroid dose less than or equal to 10 mg prednisone equivalent once daily at week 24. Based on the phase II positive data, AbbVie is advancing upadacitinib to phase III development for SLE.
AbbVie also announced positive data from a phase III induction study evaluating Skyrizi (risankizumab) to treat moderately to severely active ulcerative colitis. The data showed that a significantly higher proportion of patients, 20.3% treated with risankizumab achieved the primary endpoint of clinical remission compared to 6.2% of patients on placebo at week 12. The study also met all secondary endpoints, including clinical, endoscopic and histologic outcomes. Skyrizi is presently approved for Crohn's disease, psoriatic arthritis and psoriasis.
Roche & Lilly’s Alzheimer’s Collaboration: Roche announced a collaboration with Lilly for the development of Elecsys Amyloid Plasma Panel (EAPP), its blood test for earlier diagnosis of Alzheimer’s disease. The FDA had granted Breakthrough Device Designation to EAPP in July last year. Lilly has donanemab and remternetug in its Alzheimer’s pipeline. In January, the FDA issued a CRL to Lilly’s biologics license application for donanemab for treating early symptomatic Alzheimer's disease.
The NYSE ARCA Pharmaceutical Index declined 1.8% 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, AstraZeneca rose the most (1.9%), while Merck declined the most (2.9%).
In the past six months, AstraZeneca has risen the most (26.9%), while Roche has declined the most (9.5%).
(See the last pharma stock roundup here: M&A Boom in Drug Industry With PFE & SNY Deals, Other Updates)
What's Next in the Pharma World?
Watch out for regular pipeline and regulatory updates next week.