US FDA approval tracker: May 2021
Last month ended with a flurry of US FDA decisions and one, the green light for Amgen’s Lumakras, came over two months early. The accelerated approval in NSCLC patients with a Kras G12C mutation was given to the 960mg dose; a 240mg dose is the subject of a postmarketing study to see whether it has a similar clinical effect. Two other oncology drugs gained first-time accelerated approvals: J&J’s Rybrevant and Bridgebio’s Truseltiq. Both have confirmatory trials under way. After two previous complete response letters it was finally good news for Heron’s pain therapy Zynrelef, an extended-release bupivacaine combined with the anti-inflammatory meloxicam. To try and gain market share Heron is pricing Zynrelef at a 22-28% discount to Pacira’s Exparel; Evercore ISI analysts note that this price will also allow Heron’s drug to compete with generic bupivacaine. With May now over all eyes rest on aducanumab’s June 7 Pdufa, the biggest regulatory event of the year (Go or no go? Aducanumab’s day of reckoning, May 27, 2021).
| Notable first-time US approval decisions in May | ||||
|---|---|---|---|---|
| Project | Company | Indication | 2026e sales by indication ($m) | Outcome |
| Lumakras (sotorasib) |
Amgen | NSCLC with Kras G12C mutation after at least one systemic therapy | 1,756 | Approved (~2.5mth early, accelerated) |
| Myfembree (relugolix) | Myovant | Uterine fibroids | 490 | Approved |
| Zynrelef (HTX-011) |
Heron Therapeutics | Post-op pain relief | 471 | Approved |
| Lybalvi (ALKS 3831) |
Alkermes | Schizophrenia and bipolar 1 disorder | 380 | Approved |
| Empaveli (pegcetacoplan) | Apellis | PNH (including treatment naive) | 309 | Approved |
| Truseltiq (infigratinib) |
Bridgebio Pharma | 2L cholangiocarcinoma | 253 | Approved (accelerated) |
| Rybrevant (amivantamab) |
J&J | NSCLC with EGFR exon 20 insertion mutations | 250 | Approved (~2mth early, accelerated) |
| Pylarify (PyL) | Lantheus Holdings | Prostate cancer diagnostic imaging agent | 233 | Approved |
| Zonisamide oral suspension | Eton/Azurity Pharmaceuticals | Partial seizures in epilepsy | - | No decision yet |
| Dehydrated alcohol injection (DS-100) | Eton | Methanol poisoning | - | CRL (CMC) |
| Camcevi | Foresee Pharmaceuticals | Advanced prostate cancer | - | Approved |
| Source: Evaluate Pharma & company releases. | ||||
| Advisory committee meetings in May | ||||
|---|---|---|---|---|
| Project | Company | 2026e sales by indication ($m) | Outcome | Note |
| Vynpenta (avacopan) |
Chemocentryx | 639 | Efficacy vote split (9-9), safety profile and benefit-risk votes slightly in favour (10-8) | ANCA-associated vasculitis, Pdufa in July (Chemocentryx’s future in doubt as avacopan foundation crumbles) |
| Teplizumab (PRV-031) |
Provention Bio | - | Voted 10-7 that benefits outweigh risks in support of approval | Delay of clinical type 1 diabetes in at-risk individuals (Provention’s diabetes project takes a tentative step forward) |
| Source: Evaluate Pharma & FDA adcom calendar | ||||
| Supplementary and other notable approval decisions in May | |||
|---|---|---|---|
| Product | Company | Indication (clinical trial) | Outcome |
| Opdivo | Bristol Myers Squibb | Adjuvant oesophageal/gastroesophageal junction cancer (Checkmate-577) | Approved |
| Zeposia | Bristol Myers Squibb | Ulcerative colitis (True North) | Approved |
| Nurtec ODT | Biohaven | Prevention of migraine (Study 305, 201) | Approved |
| Ferriprox | Chiesi | Transfusional iron overload due to sickle cell disease or other anaemias in adults and paediatrics aged 3 and older | Approved |
| Keytruda + Herceptin + chemo | Merck & Co | 1L Her2+ gastric or gastroesophageal junction adenocarcinoma (Keynote-811) | Approved (accelerated) |
| Cosentyx | Novartis | Moderate-severe plaque psoriasis in children and adolescents (NCT03668613, NCT02471144) | Approved |
| Nuzyra | Paratek | Oral only dosing regimen for the treatment of community-acquired bacterial pneumonia | Approved |
| MSB11455 (Neulasta biosimilar) | Fresenius | Reduce the incidence of infection associated with febrile neutropenia | No decision yet |
| Esbriet | Roche | Unclassifiable interstitial lung disease (NCT03099187) | No decision yet |
| Aubagio | Sanofi | Paediatric relapsing MS (Terikids) | No decision yet |
| Alecensa | Roche | First-line Alk-positive NSCLC (Bfast) | No decision yet |
| Source: Evaluate Pharma & company releases. | |||
| FDA Covid-19 EUAs | |||
|---|---|---|---|
| Product | Company | 2026e sales by indication ($m) | Note |
| Comirnaty | Pfizer | 1,784 | Expanded to include 12 to 15-year-olds |
| Sotrovimab (VIR-7831) |
Vir/GSK | 1,212 | Treatment of mild-moderate Covid-19 in adults and paediatrics (US appetite for Covid-19 treatments remains undiminished) |
| Source: Evaluate Pharma & company releases. | |||
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