This week an FDA panel voted in favor of approving Pfizer’s PFE experimental maternal RSV vaccine candidate. The FDA approved AbbVie’s ABBV Rinvoq for its seventh indication, Crohn’s Disease and granted Fast Track Designation to Bayer’s BAYRY asundexian atrial fibrillation program. Roche’s RHHBY BTK inhibitor, fenebrutinib, significantly reduced brain lesions in people with relapsing forms of multiple sclerosis in a mid-stage study.
Recap of the Week’s Most Important Stories
FDA Approves AbbVie’s Rinvoq for Crohn’s Disease: The FDA approved AbbVie’s Rinvoq for the treatment of adult patients with moderately to severely active Crohn's disease for patients who have had an inadequate response or intolerance to one or more TNF blockers. The approval was based on results from two induction studies and one maintenance study, which showed that Rinvoq achieved the co-primary endpoints of clinical remission and endoscopic response as an induction and maintenance treatment. Crohn’s disease becomes the seventh FDA-approved indication for Rinvoq across gastroenterology, rheumatology and dermatology in the United States. It is already approved for treating rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, atopic dermatitis, axial spondyloarthropathy and ulcerative colitis in certain patients in several countries.
FDA Committee Votes in Favor of Pfizer’s RSV Vaccine for Maternal Immunization: Pfizer announced that the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) has voted in favor of its RSV bivalent vaccine candidate PF-06928316 or RSVpreF to help prevent RSV in infants through maternal immunization. The committee voted 10 to 4 on safety and 14 to 0 on effectiveness. The vaccine candidate is under FDA review, with a decision expected in August.
If approved by the FDA, RSVpreF will help prevent medically attended lower respiratory tract disease (MA-LRTD) and severe MA-LRTD caused by RSV in infants from birth up to six months of age by active immunization of pregnant individuals. Pfizer’s BLA seeking approval of the RSV vaccine for older adults (aged 60 and above) is already under priority review, with the FDA decision expected later this month. The VRBPAC had also voted in favor of the RSV vaccine for older adults in February 2023. The vaccine candidate is also under review for both older adults and maternal immunization in Europe.
Pfizer is planning a debt offering worth $31 billion to fund its pending acquisition of cancer drugmaker, Seagen SGEN. In March, Pfizer offered to buy Seagen for $229 per share in cash, which adds up to a total enterprise value of approximately $43 billion. Seagen’s acquisition is expected to strengthen Pfizer’s portfolio of cancer drugs by adding a class of antibody-drug conjugates (ADCs).
The bond sale is probably one of the largest debt offerings of all time. The debt offering, which will consist of eight tranches of notes, is expected to be closed on May 19. Pfizer said that BofA Securities, Citigroup, Goldman Sachs and J.P. Morgan are acting as the joint lead managers and joint book-running managers.
Roche’s BTK inhibitor, Fenebrutinib Meets Goals in Multiple Sclerosis Study: Roche’s data from a phase II study showed that BTK inhibitor fenebrutinib significantly reduced brain lesions in adults with relapsing forms of multiple sclerosis. The phase II FENopta study met its primary endpoint by reducing the total number of new gadolinium-enhancing T1 brain lesions, as measured by magnetic resonance imaging (MRI). The study also met its key secondary endpoint by significantly reducing the total number of new or enlarging T2 brain lesions compared to placebo. T1 lesions are a marker of active inflammation while T2 lesions represent the amount of lesion load.
FDA’s Fast Track Status to Bayer’s Stroke Prevention Candidate: The FDA granted fast track designation to Bayer’s oral FXIa inhibitor, asundexian (BAY2433334) as a potential treatment option for stroke prevention and systemic embolism in people with atrial fibrillation (AF). Asundexian already enjoys the FDA’s Fast Track Designation for the prevention of stroke in patients after a non-cardioembolic ischemic stroke. Asundexian is currently being evaluated in two large phase III multinational studies, OCEANIC-AF and OCEANIC-STROKE for stroke prevention.
The NYSE ARCA Pharmaceutical Index declined 1.67% in the last five trading sessions.
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, Lilly rose the most (up 0.6%), while Merck declined the most (3%).
In the past six months, Lilly has risen the most (21.2%), while Pfizer has declined the most (24.3%).
(See the last pharma stock roundup here: BAYRY Mixed Q1 Results, AZN, RHHBY Regulatory/Pipeline Updates)
What's Next in the Pharma World?
Watch out for regular pipeline and regulatory updates next week.
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