US FDA approval tracker: November

Snippets

Last month was big on FDA knockbacks, with the coronavirus pandemic playing a major part. Five complete response letters were disclosed due to chemistry, manufacturing and control issues, and there were two Pdufa delays as travel restrictions hampered manufacturing inspections. The new Pdufa date for one of the delayed projects, Bristol’s lisocabtagene maraleucel, has not yet been announced and the company is edging ever closer to the CVR deadline of December 31. On the approval side, Alnylam’s Oxlumo was given the green light a week early; it is used to treat primary hyperoxaluria type 1, a rare genetic disease. Another rare disease player, Rhythm, received its first ever approval: Imcivree gained the thumbs up in pro-opiomelanocortin deficiency obesity and leptin receptor deficiency obesity. However, only around 30 patients have been identified and Rhythm does not plan to deploy a salesforce yet. Phase III data are due soon in the bigger indication of Bardet-Biedl syndrome and there are plans for a basket trial to expand into additional genetically defined obesities. Three emergency use authorisations were granted for Covid-19 treatments last month, but all eyes are on December when two vaccines could get FDA backing.

Notable first-time US approval decisions in November
Project Company 2026e sales by indication ($m) Outcome Reason for CRL/delay?
Liso-cel/JCAR017/Breyanzi  Bristol Myers Squibb 1,155 Delayed (no new date disclosed) Manufacturing inspection delay
Imcivree (setmelanotide) Rhythm 955 Approved -
Dostarlimab Glaxosmithkline 571 No decision yet (Q4 date) -
Sutimlimab Sanofi 553 CRL CMC
LIQ861 Liquidia Technologies 476 CRL CMC
ALKS 3831  Alkermes 362 CRL CMC
RT002/
DaxibotulinumtoxinA/
DAXI 
Revance 350 Delayed (no new date disclosed) Manufacturing inspection delay
SPN-812 Supernus 279 CRL CMC
Oxlumo (lumasiran) Alnylam 253 Approved ~1 week early -
Danyelza (naxitamab) Y-mabs 247 Approved -
Zimhi Adamis 174 CRL CMC
Zokinvy (Ionafarnib) Eiger 99 Approved -
AR19 Arbor - Not disclosed (private company) -
Sources: EvaluatePharma & company releases.

 

Advisory committee meetings in November
Project Company 2026e sales by indication ($m) Outcome Note
Aducanumab Biogen/Eisai 4,757 Negative Positive briefing docs but negative panel meeting, Pdufa set for March 5 2021 (Aducanumab: this time it’s personal)
Hydexor
(CL-108)
Charleston Laboratoris/
Olas Pharma
- Negative Received first CRL in 2017 and negative adcom in 2018, second CRL afterwards
Sources: FDA ad com calendar, EvaluatePharma.

 

FDA issued EUAs to treat Covid-19
Project Company 2026e sales by indication ($m) Setting
Olumiant plus Veklury Eli Lilly 1,729* Confirmed Covid-19 in hospitalised patients
Bamlanivimab
(LY-CoV555) 
Eli Lilly - Mild-to-moderate Covid-19
Casirivimab plus imdevimab
(REGN-COV2)
Regeneron 31 Mild-to-moderate Covid-19 (The pandemic response roars on)
*Veklury received full FDA approval as a single agent in October. Sources: FDA.gov, EvaluatePharma.

 

Supplementary and other notable approval decisions in November
Product Company Indication (clinical trial) Outcome
Xofluza Roche Three decisions:
1) new formulation as one-dose granules for oral suspension, 
2) for the treatment of acute uncomplicated influenza in children aged 1-12, 
3) post-exposure prophylaxis of influenza in people aged 12 and over (miniStone-2 and Blockstone)
Approved for 1) and 3), not yet approved in paediatric setting
Keytruda + chemo Merck & Co Triple-negative breast cancer (≥10% PD-L1 expressers) (Keynote-355 Approved
Brilinta Astrazeneca/ Merck & Co Acute ischaemic stroke or transient ischaemic attack (Thales) Approved
Imfinzi Astrazeneca Four-week fixed-dose regimen for NSCLC and bladder cancer (several trials, incl Caspian) Approved
Sources: EvaluatePharma & company releases.

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