US FDA approval tracker: July

Snippets

Last month saw three early FDA approvals, including that of Morphosys and Incyte’s Monjuvi, an anti-CD19 antibody that last week won a better-than-expected second line label to treat large B-cell lymphoma. With the filgotinib verdict yet to emerge for Gilead and Galapagos, Monjuvi becomes the most notable new approval in terms of sales potential for July – filgotinib received a positive opinion in Europe and hopes are high for a green light in the US in August. A second Car-T approval also arrived early for Gilead. KTE-X19, now branded Tecartus, was waved through in mantle cell lymphoma. Other big decisions in the US last month included Jazz’s new narcolepsy treatment, Xywav; this is a low sodium follow-on to Xyrem, which will see generic competition in 2023, so Jazz needs to make the most of the Xyway opportunity. GW Pharma meanwhile added tuberous sclerosis to the label for Epidiolex, putting more ground between it and competitor Zogenix. And GSK’s anti-BCMA ADC, belantamab mafadotin, got a positive adcom vote for myeloma, despite underwhelming efficacy and safety issues. This makes an approval likely in August, although black box warnings and a REMS programme will likely be required (Go or no go? Valuable drugs set for FDA decisions, July 29, 2020).

Notable first-time US regulatory verdicts in July
Project Company 2026e sales by indication ($m) Outcome
Filgotinib Gilead/Galapagos 1,290 No decision yet
Belantamab mafodotin GSK 1,240 Positive, voted 12-0, PDUFA due in August
Monjuvi
(tafasitamab) + lenalidomide
Morphosys/Incyte 687 Approved
(~1 month early)
Dostarlimab GSK/
Anaptysbio
507 No decision yet
Xywav (JZP-258) Jazz 420 Approved
Somapacitan/
NN8640
Novo Nordisk 319 No decision yet
Upneeq/
RVL-1201
Osmotica 309 Approved
 
Rukobia
(fostemsavir)
GSK/Bristol Myers Squibb 282 Approved
Byfavo Cosmo/
Paion/
Acacia Pharma
269 Approved
VP-102 Verrica 260 CRL
Inqovi
(C-Dec/ASTX727)
Otsuka 77 Approved
(~1 month early)
Ryanodex Eagle 4 Postponed to Aug 8
Camcevi Foresee Pharmaceuticals - No decision yet
E-58425 Esteve - No decision yet
Vocabria (cabotegravir) Shionogi/GSK - No decision yet
Wynzora MC2 Therapeutics - Approved
Tecartus
(brexucabtagene autoleucel/ KTE-X19)
Gilead/Kite - Approved
(~2 weeks early)
Xeglyze Dr. Reddy's Laboratories - Approved
Sources: EvaluatePharma, Go or no go? Pandemic looms over FDA timelines, company releases

 

Supplementary and other notable approval decisions in July
Product Company Indication (clinical trial) Outcome
Xiaflex/Qwo Endo Cellulite (Release 1 and 2) Approved
Qutenza Averitas Neuropathic pain associated with diabetic peripheral neuropathy Approved
Epidiolex GW Pharmaceuticals Tuberous sclerosis (GWPCare6) Approved 
Spravato Johnson & Johnson Major depressive disorder who have active suicidal ideation with intent Approved
Trelegy Ellipta GSK Asthma (Captain) No decision yet
Tremfya Johnson & Johnson Psoriatic arthritis (Discover-1 and -2) Approved
Xolair Novartis Nasal polyps (Polyp 1 and 2) No decision yet
Bavencio Merck KGaA
/Pfizer
Locally advanced or metastatic urothelial carcinoma that has not progressed with first-line platinum-containing chemotherapy (Javelin Bladder 100) Approved
Hulio (Humira biosimilar) Mylan RA, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn's disease, ulcerative colitis and plaque psoriasis Approved
Keytruda + Lenvima Merck 1L liver cancer (Keynote-524) CRL 
Botox Abbvie Spasticity in paediatric patients aged ≥2 years, including those with lower limb spasticity caused by cerebral palsy Approved
Dysport Ipsen Spasticity in paediatric patients aged ≥2 years, including those with lower limb spasticity caused by cerebral palsy Approved
Breztri Aerosphere Astrazeneca COPD (Ethos) Approved
Tecentriq +
Cotellic +
Zelboraf
Roche/Exelixis Braf V600 mutation-positive advanced melanoma patients (Imspire150) Approved
Sources: EvaluatePharma, Go or no go? Pandemic looms over FDA timelines, company releases

 

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