FDA Cracks Down: Alvotech, Otsuka Face the Music

After a week of relative quiet, the FDA is gearing up for a busy April. This month, the agency will decide on the approval of a Humira biosimilar, as well as hold an Adcomm meeting for an Alzheimer’s agitation treatment. Additionally, two vaccine hopefuls are set to receive their decision dates.

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

Alvotech, an Iceland-based biopharmaceutical company, is on the brink of revolutionizing the therapeutic antibody market with AVT02, its biosimilar to AbbVie’s Humira (adalimumab). If approved, AVT02 could be used to treat a multitude of conditions such as rheumatoid arthritis, Crohn’s disease, ulcerative colitis and plaque psoriasis. An exciting development for those who need effective and affordable treatments for these conditions!

April 13th marks a significant milestone for AVT02, as it is the date of their Biosimilar User Fee Amendment action. This is an event of great anticipation, as its outcome has the potential to open up new possibilities for the future.

AVT02, a monoclonal antibody, has been approved as a Humira biosimilar in multiple countries around the world, including the E.U., Canada and Australia. This innovative treatment is already being utilized in many of these countries, bringing relief to those in need.

In November 2020, the FDA accepted AVT02’s Biologics License Application, but was forced to defer action due to a legal dispute between AbbVie and Alvotech.

In an attempt to challenge AbbVie’s stronghold on the arthritis market, Alvotech filed a lawsuit against the American company in December 2021. AbbVie retaliated with an overwhelming 60 patent claims, but the two managed to settle the dispute in March 2022 with an undisclosed amount.

In February 2022, the FDA revisited Alvotech’s case and, come December, handed them a Complete Response Letter. This letter indicated that in order for the investigational biosimilar to gain approval, a successful and satisfactory inspection of Alvotech’s manufacturing facility in Iceland must be completed.

Alvotech has recently released its new biosimilar product, AVT02, to the market. Data from clinical trials shows that it is a true interchangeable to Humira, offering the same levels of clinical efficacy, immunogenicity and safety in treated patients. Alvotech and its exclusive partner Teva Pharmaceuticals are thrilled to bring this product to the market and are confident that it will make a positive impact.

Adcomm Convenes to Discuss Pill for Alzheimer’s Agitation

On April 14, the FDA’s Psychopharmacologic and Peripheral and Central Nervous System Drugs Advisory Committees will come together to review Otsuka Pharmaceutical Company’s sNDA for Rexulti (brexpiprazole) tablets and decide if it should be approved for use. This marks an exciting step forward in evaluating the potential of this new drug, with the hopes of providing an effective treatment for those who need it most.

Otsuka is aiming to broaden the scope of Rexulti’s label to encompass agitation in patients with Alzheimer’s disease, offering hope to those struggling with this difficult condition.

In July 2022, Rexulti achieved a major milestone in its Phase III trial, demonstrating significant improvements in the Cohen-Mansfield Agitation Inventory, a validated caregiver-rated questionnaire to assess agitation, compared to placebo. Otsuka is now set to present these results to the FDA for an sNDA submission by the end of the year, a major step in the drug’s journey towards market availability.

In December 2022, three more Phase III studies revealed the promising therapeutic potential of Rexulti for a specific indication, further solidifying its position as a potential game-changer in the industry. With its impressive results, Rexulti could potentially revolutionize patient care and make a lasting impact on health outcomes.

In 2015, Rexulti was approved by the FDA for the treatment of schizophrenia and as an adjunctive therapy for major depressive disorder. Fast forward to January 2022, and Rexulti was expanded to treat schizophrenia in teenagers aged 13 to 17 years. This innovative drug was discovered by Otsuka and is being co-developed with Lundbeck to provide improved mental health treatment for young people.

Pfizer to Add New Serotypes to its Pneumococcal Conjugate Vaccine

This month, the FDA is set to make a pivotal decision on Pfizer’s supplemental Biologics License Application (sBLA) for their groundbreaking 20-valent pneumococcal conjugate vaccine candidate. This vaccine, if approved, would offer protection against Streptococcus pneumoniae, a potentially deadly and debilitating bacterial infection. The decision is eagerly anticipated by the medical and public health communities, and the implications of its passage could be far-reaching.

The FDA granted Pfizer’s sBLA a Priority Review designation in January, drastically reducing the review period by four months. This speedy evaluation process is a testament to the potential of this new therapeutic, paving the way for a faster and more efficient path to patient treatment.

Pfizer’s candidate vaccine expands upon its already approved Prevnar 13, with an additional seven serotypes known to cause invasive pneumococcal disease worldwide. These serotypes pose a high risk of mortality, complications, and antibiotic resistance, and are thus crucial to protect against.

Pfizer’s Prevnar 20 vaccine is a powerful tool for fighting pneumonia in adults aged 18 or up. Now, the company is hoping to expand the vaccine’s reach by submitting a Supplemental Biologics License Application to the FDA, which would allow Prevnar 20 to protect children from 6 weeks through 17 years of age from the same 20 strains of pneumonia.

The Phase II and Phase III pediatric programs for the 20-valent vaccine candidate provided compelling evidence of its efficacy, immunogenicity and safety, which enabled the successful submission of a sBLA application. The data from these programs demonstrated a favorable profile for the vaccine candidate, making it a promising solution for protecting children against disease.

If approved, Pfizer’s vaccine would be the most comprehensive of its kind, offering unparalleled protections against pneumococcal conjugate-related illnesses in babies and children. With its broad serotype coverage, this vaccine promises to be a game-changer in the fight against preventable childhood diseases.

Emergent’s Anthrax Vaccine Nears Verdict

The highly anticipated verdict on Emergent Biosolutions’ anthrax vaccine candidate AV7909 is expected to be revealed by the FDA in April. With no exact date being specified, anticipation is growing as the decision could have life-or-death implications for millions of people across the globe.

In June 2022, the FDA accepted Emergent’s Biologics License Application (BLA) for the proposed post-exposure prophylaxis AV7909 to be used in adults aged 18 to 65 after confirmed or suspected exposure to Bacillus anthracis. To ensure the best results, AV7909 should be taken with recommended antibacterial agents.

In April 2022, Emergent completed its rolling submission for the Biologics License Application (BLA) for its AV7909 vaccine candidate, with data from a pivotal Phase III clinical trial, as well as data from a Phase II study which showed that the vaccine did not interfere with antibacterial drugs for anthrax. The Phase III trial assessed the immunogenicity and safety of a two-dose regimen of AV7909, as well as its lot consistency.

The development of AV7909 was made possible thanks to the generous support of the Biomedical Advanced Research and Development Authority, allowing it to reach its full potential. Their investment in this project has enabled cutting-edge advances in healthcare to be achieved.

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