US FDA approval tracker: June

Snippets

Four products received complete response letters in June, the most noteworthy of which was Intercept’s obeticholic acid. After two postponed panel meetings the FDA finally gave a thumbs down to the wannabe Nash treatment, wiping 40% off Intercept’s share price. Meanwhile Keytruda got three separate approvals including a second for a biomarker-based indication. The drug not only dominates the PD-(L)1 space: Keytruda is forecast to become the biggest selling drug in 2023, with sales in 2026 seen reaching almost $25bn, according to EvaluatePharma's consensus. Meanwhile a decision for Novartis’s subcutaneous formulation of ofatumumab in multiple sclerosis, formerly known as the cancer drug Arzerra, was delayed until September. With the pandemic showing few signs of abating, particularly in the US, investors should perhaps be braced for further delays to approvals in the coming months (Go or no go? Pandemic looms over FDA timelines, July 1, 2020).

Notable first-time US approval decisions in June
Project Company 2026e indication sales ($m) Outcome
Ocaliva
(obeticholic acid)
Intercept 2,750 CRL
HTX-011 Heron 526 CRL
Uplizna
(inebilizumab)
Viela Bio 518
(neuromyelitis optica)
Approved
Zepzelca/
Zepsyre
(lurbinectedin)
Jazz/Pharmamar 397 Approved
(~2 months early)
Fintepla Zogenix 369
(Dravet)
Approved
Dojolvi/
UX007/
triheptanoin
Ultragenyx 268 Approved
(~1 month early)
Posimir Durect 221 No decision yet
Abicipar  Abbvie 206 CRL
Contepo Nabriva 115 CRL
Gimoti Evoke 72 Approved
Aximris XR
(oxycodone extended-release tablets)
Intellipharmaceutics International 43 No decision yet
Travivo Fabre-Kramer Pharmaceuticals - No decision yet
Mycapssa Chiasma - Approved
Sources: EvaluatePharma, Go or no go? A busy month ahead for US FDA decisions, company releases

 

Supplementary and other notable approval decisions in June
Product Company Indication (clinical trial) Outcome
Cosentyx Novartis Active non-radiographic axial spondyloarthritis Approved
Crysvita/
borosumab
Ultragenyx FGF23-related hypophosphatemia associated with phosphaturic mesenchymal tumours (NCT02304367, NCT02722798) Approved
Cyramza + erlotinib Eli Lilly Previously untreated patients with EGFR mutation-positive metastatic NSCLC (Relay) Approved
Gardasil 9  Merck Prevention of oropharyngeal and other head and neck cancers caused by HPV types 16, 18, 31, 33, 45, 52, and 58 Approved
Ilaris Novartis Active Still’s disease Approved
Juvederm Voluma XC Abbvie Enhancement of the chin region Approved
Keytruda Merck Adult and paediatric patients with unresectable or metastatic solid tumors with tissue tumor mutational burden-high ≥10 mutations/megabase (Keynote-158) Approved
Keytruda Merck Recurrent and/or metastatic
cutaneous squamous cell carcinoma that is not curable by surgery or radiation (Keynote-629)
Approved
Keytruda Merck 1L unresectable/metastatic MSI-H or dMMR colorectal cancer (Keynote-177) Approved
Nyvepria
(Neulasta biosimilar)
Pfizer Decrease the incidence of infection, as manifested by febrile neutropenia Approved
Opdivo BMS Advanced oesophageal squamous cell carcinoma (Attraction-3) Approved
Phesgo
(fixed-dose combination of Perjeta and Herceptin)
Roche Her2-positive breast cancer (FeDeriCa) Approved
Recarbrio Merck Hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (Restore-Imi 2) Approved
Semglee/
insulin glargine (Lantus biosimilar)
Biocon Diabetes type I and II Approved
Subcutaneous ofatumumab/
Arzerra SC/
OMB157
Novartis Relapsing multiple sclerosis (Asclepios I and II) Delayed to September
Tazverik Epizyme Relapsed or refractory FL who have received at least two prior lines of systemic therapy (NCT01897571) Approved
Tivicay and
Tivicay PD
GSK/Shionogi Treat HIV-1 infection in paediatric patients at least four weeks old Approved
Xpovio Karyopharm Therapeutics RR DLBCL who have received at least two prior therapies (Sadal) Approved
Sources: EvaluatePharma, Go or no go? A busy month ahead for US FDA decisions, company releases

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