US FDA approval tracker: June 2020
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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