Notable first-time US approval decisions in May
| Project | Company | Indication(s) | 2028e sales by indication (SBI) ($m) | Outcome |
| Mounjaro (tirzepatide) |
Lilly | Type 2 diabetes | 8,132 | Approved |
| Bimzelx | UCB | Plaque psoriasis | 1,191 | CRL (pre-approval inspections) |
| AXS-05 | Axsome | Major depressive disorder | 787 | Pending (Q2) |
| FT218 | Avadel | Treatment of excessive daytime sleepiness or cataplexy in adults with narcolepsy | 361 | Full approval not expected until mid-2023, when Jazz's '963 REMS patent expires |
| VP-102 | Verrica | Molluscum contagiosum | 359 | CRL (deficiencies at CMO) |
| Miglustat | Amicus | Pompe disease | 266* | Delayed to Aug 29 (cipaglucosidase Pdufa also delayed to Oct 29, combination product known as AT-GAA) |
| Vtama (tapinarof) | Dermavant | Plaque psoriasis | - | Approved |
| Annik (penpulimab) | Akeso/Sino | 3L nasopharyngeal carcinoma | - | Pending (H1) |
| Voquenza triple pak, Voquenza dual pak (vonoprazan) |
Phathom | Adults with H pylori infection | - | Approved |
| Radicava ORS (MT-1186, oral edaravone) | Mitsubishi Tanabe | ALS | - | Approved |
| Lamotrigine (ET-105) for supspension | Eton/Azurity | Epilepsy | - | CRL |
| *Forecasts for AT-GAA. Source: Evaluate Pharma & company releases. | ||||
2022/06/06
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