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Here is information on the latest US FDA approvals, the week of August 21 – August 25, 2023.
FDA Approves Tyruko as First Biosimilar to Tysabri
The FDA has approved Tyruko (natalizumab-sztn), the first biosimilar to Tysabri (natalizumab) injection for the treatment of adults with relapsing forms of multiple sclerosis (MS). A biosimilar is a biological product that is highly similar to, and has no clinically meaningful differences from, a biological product already approved by the FDA (also called the reference product). The prescribing information for natalizumab products (including Tyruko and Tysabri) contains a boxed warning about increased risk of progressive multifocal leukoencephalopathy (PML), a viral infection of the brain that usually leads to death or severe disability. Because of the risks of PML, natalizumab products are available only through a REMS program. The most common side effects associated with natalizumab products are headache and fatigue. The FDA granted approval of Tyruko, the first biosimilar to Tysabri (natalizumab), to Sandoz Inc. Tyruko is also indicated for inducing and maintaining clinical response and remission in adult patients with moderately to severely active Crohn’s Disease.
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761322s000lbl.pdf
Abrysvo RSV Maternal Immunization Approved
The FDA has approved Abrysvo, a bivalent RSV prefusion F (RSVpreF) vaccine, for the prevention of lower respiratory tract disease (LRTD) and severe LRTD caused by RSV in infants from birth up to six months of age. The new approval allows for the immunization of pregnant individuals at 32 through 36 weeks gestational age. Abrysvo is unadjuvanted and composed of two preF proteins selected to optimize protection against RSV A and B strains. The FDA’s decision is based on the data from the pivotal Phase 3 clinical trial MATISSE (MATernal Immunization Study for Safety and Efficacy), a randomized, double-blinded, placebo-controlled Phase 3 study published in The New England Journal of Medicine in April 2023. RSV is a common cause of respiratory illness worldwide. The virus can affect the lungs and breathing passages of an infected individuals, potentially causing severe illness or death. In the US, approximately 500,000 infants experience LRTD due to RSV each year and it is a leading cause of hospitalization in children younger than one year of age. Abrysvo was also approved for the prevention of RSV in Adults aged 60 and older on May 31, 2023. Abrysvo is manufactured by Pfizer Inc.
https://labeling.pfizer.com/ShowLabeling.aspx?id=19589
sBLA Filed for Rybrevant in Advanced NSCLC
A supplemental biologics license application (sBLA) has been filed with the FDA for the expanded approval of Rybrevant (amivantamab-vmjw) in combination with carboplatin and pemetrexed for the frontline treatment of patients with advanced non–small cell lung cancer with EGFR exon 20 insertion mutations. Rybrevant is a bispecific EGF receptor-directed and MET receptor-directed antibody. Rybrevant was granted a breakthrough therapy designation for this indication in May 2021. The current application comes after the phase 3 PAPILLON trial demonstrated a significant improvement in progression-free survival with Rybrevant plus chemotherapy compared to chemotherapy alone. Rybrevant is manufactured by Janssen Pharmaceuticals.
Priority Review of Xtandi in Early PCa
The FDA has granted Priority Review for a supplemental New Drug Application for Xtandi (enzalutamide) in patients with non-metastatic castration-sensitive prostate cancer with high-risk biochemical recurrence. An anticipated FDA decision for this indication is expected in the last quarter Q4 of 2023. Xtandi is an androgen receptor signaling inhibitor already indicated for use in later stages of prostate cancer. The new approval would indicate Xtandi earlier in the course of disease. The sNDA is based on results from the Phase 3 EMBARK trial. Xtandi was evaluated in combination with leuprolide and showed a significant 58% reduction in the risk of metastasis or death compared with placebo plus leuprolide. Xtandi is manufactured by Pfizer, Inc.
Upcoming PDUFA dates
There is a target PDUFA date of Monday August 28th for Bristol Myers Squibb’s Reblozyl® (luspatercept-aamt). The new approval, if granted, will expand the drugs current indication to include treatment of anemia without previous use of erythropoiesis-stimulating agents (ESA-naïve) in adult patients with very low- to intermediate-risk myelodysplastic syndromes (MDS) who may require red blood cell (RBC) transfusions.
https://packageinserts.bms.com/pi/pi_reblozyl.pdf
ONS-5010/Lytenava is an investigational ophthalmic formulation of bevacizumab for the treatment of wet age-related macular degeneration manufactured by Outlook Therapeutics. The PDUFA goal date is Tuesday August 29, 2023. ONS-5010, if approved, is expected to receive 12 years of regulatory exclusivity in the United States.
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