US FDA approval and panel tracker: July 2023

Eisai and Biogen’s Leqembi received full approval to treat Alzheimer’s disease last month. That was expected; what was not was that the label came with a boxed warning over Aria, a brain swelling disorder, with recommendation for ApoE4 genetic testing to assess Aria risk. Leqembi’s launch is under way with Biogen highlighting on its quarterly call that it has Medicaid coverage in 48 states so far. Elsewhere good news finally came for Verrica’s Ycanth after three previous complete response letters. This is the first FDA-approved therapy to treat molluscum contagiosum, a viral condition that creates a localised skin infection. There was also good news for Astrazeneca and Sanofi’s Beyfortus, an antibody to prevent respiratory syncytial virus (RSV) in young children. Sanofi noted on its second-quarter call that it is confident of a broad recommendation at the ACIP meeting on 3 August, and will price the therapy like a premium vaccine. Hot on its heels is Pfizer’s Abrysvo, due a Pdufa decision as a maternal RSV vaccine later this month.

Notable first-time US approval decisions in July 2023
Project Company Indication(s) 2028e SBI ($m) Outcome
Beyfortus (nirsevimab) Astrazeneca/Sanofi/Sobi Prevention of RSV lower respiratory tract disease in neonates and infants born during or entering their first RSV season, and in children up to 2 years old who remain vulnerable to severe disease through their second season 1,727 Approved
Qdenga (TAK-003) Takeda Dengue vaccine (4-60 years) 922 BLA withdrawn (data collection issues)
Xdemvy (TP-03) Tarsus Demodex blepharitis 497 Approved
Verrica Molluscum contagiosum in patients 2 years and older 212 Approved
Cyfendus (AV7909) Emergent Biosolutions Two-dose anthrax vaccine for post-exposure prophylaxis use 212 Approved
Lymphir (denileukin diftitox, I/Ontak, E7777)  Citius Pharmaceuticals  Cutaneous persistent or recurrent T-cell lymphoma 195 CRL
Quizartinib (Vanflyta) + standard cytarabine and anthracycline induction Daiichi Sankyo Newly diagnosed FLT3-ITD­ +ve AML  116 Approved
Risvan (Doria/
risperidone ISM)
Laboratorios Farmacéuticos ROVI Schizophrenia - CRL
Balfaxar (Octaplex) Octapharma Warfarin reversal in urgent surgery and invasive procedures - Approved
Sources: Evaluate Pharma & company releases.


Supplementary and other notable approval decisions in July 2023
Product Company Indication (clinical trial) Outcome
Leqembi Eisai/Biogen Alzheimer's disease - full approval Approved
Leqvio Novartis Adults with high LDL-C and who are at increased risk of heart disease Approved
Veklury Gilead Covid-19 patients with severe renal impairment, including those on dialysis (Redpine) Approved
Ervebo Merck Prevention of Ebola virus disease caused by Zaire ebolavirus in individuals 1-17 years of age Approved
Jemperli + chemo Anaptysbio/GSK Adult patients with mismatch repair deficient/microsatellite instability-high primary advanced or recurrent endometrial cancer (part 1 of Ruby) Approved (~ 2 months early)
Sources: Evaluate Pharma & company releases.

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