FDA Action Alert: Alvotech, Otsuka and More

Pictured: FDA sign in front of building/Courtesy Sarah Silbiger/Getty Images

After a quiet week, the FDA is now set to decide on a Humira biosimilar and hold an Adcomm meeting for an Alzheimer’s agitation treatment. Also on its calendar for April are decision dates for two vaccine hopefuls.

Read below for more details.

Alvotech’s Biosimilar for AbbVie’s Humira Awaits FDA Decision

Iceland-based Alvotech is seeking regulatory approval for AVT02, a biosimilar to AbbVie’s therapeutic antibody Humira (adalimumab), which is indicated for rheumatoid arthritis, Crohn’s disease, ulcerative colitis and plaque psoriasis, among other conditions.

AVT02’s Biosimilar User Fee Amendment action date is on April 13.

AVT02 is a monoclonal antibody that has been approved as a Humira biosimilar in the E.U., Canada and Australia, among other territories. The treatment is also already being marketed in many of these countries.

The FDA first accepted AVT02’s Biologics License Application in November 2020, but due to a legal tussle between AbbVie and Alvotech, decided to defer action.

Seeking to break AbbVie’s monopoly on the arthritis market, Alvotech filed a lawsuit against the American company in December 2021. AbbVie retaliated with over 60 patent claims. The two reached a settlement in March 2022 for an undisclosed amount.

The FDA reconsidered Alvotech’s case in February 2022. In December of the same year the regulator handed Alvotech a Complete Response Letter stating the approval for the investigational biosimilar is contingent on successful and satisfactory inspection of the company’s manufacturing facility in Iceland.

In its application, Alvotech touted data showing that AVT02 was interchangeable with Humira, leading to comparable levels of clinical efficacy, immunogenicity and safety in treated patients. Alvotech will market AVT02 with its exclusive partner, Teva Pharmaceuticals.

Adcomm Convenes to Discuss Pill for Alzheimer’s Agitation

On April 14, the FDA’s Psychopharmacologic Drugs Advisory Committee will hold a joint meeting with the Peripheral and Central Nervous System Drugs Advisory Committee to discuss Otsuka Pharmaceutical Company’s supplemental New Drug Application (sNDA) for Rexulti (brexpiprazole) tablets.

Otsuka hopes to expand Rexulti’s label to include agitation in patients with Alzheimer’s disease.

In July 2022, Rexulti cleared a Phase III trial and elicited significant improvements in the Cohen-Mansfield Agitation Inventory, a validated caregiver-rated questionnaire to assess agitation, as compared with placebo. Otsuka planned to present these results to the FDA for an sNDA submission in late 2022.

Data from three more Phase III studies, released in December 2022, additionally highlighted the therapeutic potential of Rexulti in this indication.

Rexulti was first approved by the FDA in 2015 for schizophrenia and as an adjunctive therapy for major depressive disorder. In January 2022, the drug’s indication was expanded to allow for the treatment of schizophrenia in teenagers aged 13 to 17 years. Rexulti was discovered by Otsuka and is being co-developed with Lundbeck.

Pfizer to Add New Serotypes to its Pneumococcal Conjugate Vaccine

The FDA is also expected to decide this month on Pfizer’s supplemental Biologics License Application (sBLA) for its 20-valent pneumococcal conjugate vaccine candidate against Streptococcus pneumoniae, though no specific date has been given yet.

The FDA accepted Pfizer’s sBLA in January and gave it the Priority Review designation, which cuts the review period by four months.

Pfizer’s candidate includes the 13 serotypes covered by its approved vaccine Prevnar 13, along with seven new serotypes which are known to cause invasive pneumococcal disease globally and are associated with high case-fatality rates, complications and antibiotic resistance.

These 20 strains are also covered by Pfizer’s Prevnar 20, a vaccine for active immunization against pneumonia for patients aged 18 years or older. The sBLA hopes to expand this coverage to children from 6 weeks through 17 years of age.

Data from the Phase II and Phase III pediatric programs for the 20-valent vaccine candidate supported the sBLA application and collectively demonstrate a favorable efficacy, immunogenicity and safety profile.

If approved, Pfizer’s vaccine would have the broadest serotype coverage of any pneumococcal conjugate vaccines in babies and children.

Emergent’s Anthrax Vaccine Nears Verdict

The FDA is expected to release its verdict regarding Emergent Biosolutions’ anthrax vaccine candidate AV7909 in April, though no specific date has been set.

In its BLA, which the FDA accepted in June 2022, Emergent proposed AV7909 for post-exposure prophylaxis after confirmed or suspected exposure to Bacillus anthracis. The candidate is being evaluated for adults aged 18 through 65 years and is to be given with recommended antibacterial agents.

Emergent supported its rolling BLA with data from a pivotal Phase III clinical trial, which assessed the immunogenicity and safety of a two-dose regimen of AV7909, along with its lot consistency. Data from a Phase II study, showing that the vaccine candidate did not interfere with antibacterial drugs for anthrax, was also included in its BLA package. Emergent completed its rolling submission in April 2022.

The development of AV7909 was supported by the Biomedical Advanced Research and Development Authority.

Tristan Manalac is an independent science writer based in metro Manila, Philippines. He can be reached at tristan@tristanmanalac.com or tristan.manalac@biospace.com