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AstraZeneca's (AZN) sBLA for New Imfinzi Dosage Gets Approval

Zacks Equity Research
·4 min read

AstraZeneca AZN announced that the FDA has approved its supplemental Biologics License Application (sBLA) for its key cancer drug, Imfinzi (durvalumab). The sNDA sought approval for a new dosing regimen of the drug for the approved indications of unresectable, stage III non-small cell lung cancer (NSCLC) after chemoradiation therapy and previously treated advanced bladder cancer.

Following the approval, a 1,500mg fixed dose of Imfinzi can now be administered every four weeks in patients weighing above 30kg as an alternative to weight-based dosing of 10mg/kg every two weeks. The new dosing option will likely reduce patient visit to physicians for administration of Imfinzi from two to one in a month, improving patient convenience. We note that less-frequent dosing regimens are the need of the hour amid the ongoing coronavirus pandemic, to reduce visits to physicians due to travel restriction and fear of getting infected. Reduced patient visits to clinics hampered sales of several popular physician-administered drugs in the second and third quarters of 2020.

The approval to the new dosing regimen of Imfinzi was based on data from several clinical studies on the drug including two phase III studies.The PACIFIC study supported the two-week, weight-based dosing for NSCLC patients while the CASPIAN study supported four-week, fixed-dosing during maintenance treatment in ES-SCLC patients.

The 1,500mg fixed dose every four weeks is already approved for the drug’s third approved indication — extensive-stage small cell lung cancer.

Shares of AstraZeneca have increased 9.7% so far this year against the industry’s decrease of 0.2%.

Meanwhile, AstraZeneca initiated late-stage clinical program last week to evaluate the safety and effectiveness of the antibody cocktail, AZD7442, as a prophylactic to prevent COVID-19 infection for up to 12 months. The studies will be conducted in the United States and countries across Europe. The company believes that the candidate has the potential to prevent as well as to treat COVID-19 infection in already infected person.

AstraZeneca is also developing a coronavirus vaccine, AZD1222, in collaboration with Oxford University in several late-stage studies across several countries. In a separate press release, the company announced data from an interim analysis of clinical studies in the United Kingdom and Brazil, which showed that the vaccine candidate has achieved an average efficacy of 70%.

Please note that a vaccine and a prophylactic treatment differ in their ways of working in the human body in preventing an infection. While treatment with AZD7442 will introduce antibodies in the body that will fight the infection-causing virus, inoculation with AZD1222 will boost the human body’s immune response that will generate antibodies in turn and prevent a patient from getting infected. Moreover, AZD7442 will help people who have a weaker immune system and are already infected. AZD1222 will be beneficial for uninfected persons.

Meanwhile, several other companies are engaged in developing a vaccine or antibody treatment for COVID-19. Currently, Gilead’s GILD Veklury (remdisivir) is the only FDA-approved antiviral treatment for COVID-19. Moreover, Regeneron’s REGN antibody cocktail candidate, REGN-COV2, and Lilly’s LLY antibody drug, bamlanivimab, can also be administered in emergency cases of COVID-19 as they have gained EUA from the FDA earlier this month. Moreover, Pfizer and its partner BioNTech submitted regulatory application seeking EUA for their mRNA-based coronavirus vaccine candidate last week.

AstraZeneca PLC Price

AstraZeneca PLC Price
AstraZeneca PLC Price

AstraZeneca PLC price | AstraZeneca PLC Quote

Zacks Rank

AstraZeneca currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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