WESTON (dpa-AFX) - As we enter the new year, all eyes are on the biotech companies awaiting key FDA decisions in January.
In 2024, the FDA approved 50 novel drugs, matching the total from 2021 and making it the fourth-highest approval year. The highest number of novel drug approvals occurred in 2018 with 59, followed by 55 in 2023 and 53 in 2020.
Atara Biotherapeutics Inc. (ATRA)
Atara Biotherapeutics' T-cell immunotherapy, Tab-cel, is under FDA review, with a decision anticipated on January 15, 2025.
Tab-cel is proposed as monotherapy for the treatment of adult and pediatric patients two years of age and older with Epstein-Barr virus-positive post-transplant lymphoproliferative disease (EBV+ PTLD) who have received at least one prior therapy.
If approved, Tab-cel would be the first approved therapy in the U.S. for EBV+ PTLD.
Tab-cel, under the brand name Ebvallo, is approved in the European Union, the United Kingdom, and Switzerland as a monotherapy for the treatment of adult and pediatric patients aged two and older with relapsed or refractory EBV+ PTLD, who have received at least one previous therapy.
The company expanded its global partnership with Pierre Fabre Laboratories last November for the development, manufacturing, and commercialization of Tab-cel in the United States and all remaining markets. The initial agreement between the two companies was signed in October 2021 to commercialize Tab-cel for Epstein-Barr Virus (EBV)-positive cancers in Europe, the Middle East, Africa, and other select emerging markets.
ATRA closed Tuesday's (Dec.31, 2024) trading at $13.31, up 0.23%.
Biogen Inc. (BIIB)
The FDA decision on a monthly IV maintenance dose of Leqembi to treat people with Alzheimer's disease is expected on January 25, 2025.
Leqembi, indicated for the treatment of Alzheimer's disease in patients with mild cognitive impairment or mild dementia stage of disease (collectively referred to as early AD), was launched in the U.S. in January 2023.
The current recommended dosage of Leqembi is 10 mg/kg administered intravenously once every two weeks to eligible patients with confirmed presence of Amyloid beta (A?) pathology prior to initiating treatment.
As part of the proposed monthly IV maintenance regimen, the patients who have completed the biweekly IV initiation phase, the exact period under discussion with the FDA, would receive a monthly IV dose of Leqembi to maintain adequate drug levels to keep removing harmful protofibrils that can damage nerve cells.
The global development and regulatory submission for Leqembi is led by Eisai Co., Ltd. (ESALF.OB). The marketing and promotion responsibilities of the drug are shared by Eisai and Biogen, with Eisai making the final decisions.
BIIB closed Tuesday's trading at $152.92, up 1.82%.
AstraZeneca plc (AZN)
The FDA decision on Datopotamab Deruxtecan, proposed for the treatment of patients with previously treated metastatic HR-positive, HER2-negative breast cancer, is due on January 29, 2025.
HR+, HER2- breast cancer is the most common subtype of metastatic breast cancer, accounting for 73% of all cases.
Datopotamab deruxtecan is a specifically engineered TROP2-directed DXd antibody-drug conjugate (ADC) discovered by Daiichi Sankyo and being jointly developed by Daiichi Sankyo and AstraZeneca. TROP2 is a protein widely found in HR-positive, HER2-negative breast cancer and is linked to increased tumor progression and poor survival.
In clinical trials, Datopotamab deruxtecan demonstrated a statistically significant and clinically meaningful improvement for the dual primary endpoint of progression-free survival (PFS) compared to the investigator's choice of chemotherapy in patients with unresectable or metastatic HR-positive, HER2-negative breast cancer previously treated with endocrine-based therapy and at least one systemic therapy.
AZN closed Tuesday's trading at $65.52, down 0.08%.
Vertex Pharmaceuticals Inc. (VRTX)
On January 30, 2025, Vertex Pharma will know whether or not its investigational, oral, selective NaV1.8 pain signal inhibitor, Suzetrigine, proposed to treat moderate-to-severe acute pain, gets the FDA nod.
Acute pain, a condition which lasts for less than three months, is a debilitating one. In the U.S., it is estimated that more than 80 million people receive a prescription for acute pain management each year.
If approved, Suzetrigine, which is under priority review, has the potential to be the first new class of medicine to treat acute pain in over twenty years.
According to a report by GlobalData, Suzetrigine could achieve peak sales of $1.4 billion by 2030.
VRTX closed Tuesday's trading at $402.70, up 0.84%.
Axsome Therapeutics (AXSM)
Axsome Therapeutics Inc. (AXSM) has made a renewed effort to secure FDA approval for AXS-07 for the acute treatment of migraine, with a decision expected on January 31, 2025.
AXS-07, which consists of MoSEIC (Molecular Solubility Enhanced Inclusion Complex) meloxicam and rizatriptan, is designed to work by inhibiting Calcitonin gene-related peptide (CGRP) release, reversing CGRP-mediated vasodilation, and inhibiting neuroinflammation, pain signal transmission, and central sensitization, according to the company.
The U.S. regulatory agency declined to approve AXS-07 in May 2022, due to issues with the chemistry, manufacturing, and controls (CMC) data pertaining to the drug product and manufacturing process.
Addressing the concerns raised by the FDA, the company resubmitted the New Drug Application (NDA) for AXS-07 for the acute treatment of migraine in August of 2024, and as mentioned earlier, a decision is expected by January 31, 2025.
According to the company, if approved, AXS-07 has the potential to achieve peak sales of $500 million to $1.0 billion.
AXSM closed Tuesday's trading at $84.61, down 0.20%.
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