US FDA approval tracker: May

Snippets

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 305201) 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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