
US FDA approval tracker: July
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 |