US FDA approval tracker: July 2021
Last month saw plenty of setbacks for companies gunning for US approvals, with four complete response letters as well as a number of delays to Pdufa dates. One group that has been held up is Chemocentryx, which will now have to wait until October for the decision on Vynpenta for ANCA-associated vasculitis. The new date was given after Chemocentryx submitted a filing amendment intended to address issues raised during an earlier panel meeting. Having already been delayed to the third quarter, decisions on Jak inhibitors from Pfizer, Lilly and Abbvie have been pushed back again as the US regulators continue to review the safety profile of Pfizer's Xeljanz. The FDA has not given any guidance as to when the reviews might be completed. On a more positive note, Merck & Co’s Keytruda added more indications to its armoury, including neoadjuvant and adjuvant use in triple-negative breast cancer. However, the drug's accelerated approval in third-line gastric cancer was voluntarily withdrawn following an FDA-backed panel meeting in April.
| Notable first-time US approval decisions in July | ||||
|---|---|---|---|---|
| Project | Company | Indication(s) | 2026e sales by indication ($m) | Outcome |
| Kerendia (finerenone) |
Bayer | CKD and type 2 diabetes | 896 | Approved |
| Rezurock (belumosudil/ KD025) |
Kadmon | Chronic graft vs host disease | 863 | Approved (~6wks early) |
| Vaxneuvance (V114) |
Merck & Co/Ligand | Pneumococcal infection vaccine (adults) | 786 | Approved |
| Ibsrela (tenapanor) | Ardelyx | Control of serum phosphorus in adult patients with CKD | 701 | CRL |
| Vynpenta (avacopan) |
Chemocentryx | ANCA-associated vasculitis | 639 | Delayed to October 7 |
| Saphnelo (anifrolumab) | Astrazeneca | Moderate to severe SLE | 488 | Approved |
| Bylvay (odevixibat) |
Albireo | Progressive familial intrahepatic cholestasis | 299 | Approved |
| Sulopenem etzadroxil/probenecid (oral sulopenem) | Iterum | uUTIs | 220 | CRL |
| Retifanlimab | Incyte | Squamous cell carcinoma of the anal canal | 80 | CRL |
| Dalvance | Abbvie | Acute bacterial skin and skin structure infections in paediatric patients | 40 | Approved |
| Teplizumab (PRV-031) |
Provention Bio | Delay or prevention of type 1 diabetes in at-risk individuals | - | CRL |
| Leukotac (inolimomab) |
Gruppo Mediolanum farmaceutici | Acute steroid-resistant graft vs host disease | - | No decision yet |
| Twyneo | Sol-Gel | Acne | - | Approved |
| Fexinidazole | Sanofi/Drugs for Neglected Diseases initiative | All-oral treatment for sleeping sickness | - | Approved |
| Source: Evaluate Pharma & company releases. | ||||
| Advisory committee meeting in July | ||||
|---|---|---|---|---|
| Project | Company | Indication | 2026e sales by indication ($bn) | Outcome |
| Evrenzo (roxadustat) |
Astrazeneca/ Fibrogen/Astellas |
Anaemia due to CKD in adult patients not on dialysis and on dialysis | 2.6* | The committee voted 12-2 against approval in pts on dialysis and 13-1 against approval for pts not on dialysis |
| Source: Evaluate Pharma & company releases. *Forecasts prior to adcom. | ||||
| Supplementary and other notable approval decisions in July | |||
|---|---|---|---|
| Product | Company | Indication (clinical trial) | Outcome |
| Abrocitinib | Pfizer | Atopic dermatitis | Delayed |
| Xeljanz | Pfizer | Ankylosing spondylitis | Delayed |
| Olumiant | Lilly | Atopic dermatitis | Delayed |
| Rinvoq | Abbvie | Atopic dermatitis | Delayed |
| Keytruda | Merck & Co | Locally advanced cutaneous squamous cell carcinoma that is not curable by surgery or radiation (Keynote-629) | Approved |
| Keytruda + Lenvima | Merck & Co/Eisai | Advanced endometrial carcinoma that is not MSI-H or dMMR (Confirmatory study Keynote-775) | Approved (~6wks early) |
| Keytruda | Merck & Co | High-risk early-stage triple-negative breast cancer plus chemo as neoadjuvant treatment and then as a single agent as adjuvant treatment after surgery (Keynote-522) | Approved |
| Keytruda | Merck & Co | Full approval triple-negative breast cancer (≥10% PD-L1 expressers) (Confirmatory study Keynote-522, originally granted in Nov 2020 based on Keynote-355) | Approved |
| Padcev | Seagen/Astellas | Regular approval and expanded indication in adult patients with locally advanced or met urothelial cancer who are ineligible for cisplatin-containing chemo (EV-301, EV-201) | Approved (~1mo early) |
| Darzalex Faspro + pomalidomide + dexamethasone | J&J | Adult multiple myeloma patients who have received at least one prior line of therapy (Apollo) | Approved |
| Octagram 10% | Octapharma | Dermatomyositis in adults (Proderm) | Approved |
| Prograf | Astellas | Prevention of organ rejection in adult and paediatric lung transplant recipients. | Approved |
| Bydureon BCise (exenatide extended-release) | Astrazeneca | Once-weekly injectable suspension for type 2 diabetes in paediatric patients ages 10 years and older (BCB114) | Approved |
| Shingrix | Glaxosmithkline | Prevention of shingles in immunocompromised adults | Approved |
| Semglee (Lantus biosimilar) | Viatris | Improve glycaemic control in adults and children with Type 1 diabetes and in adults with Type 2 diabetes (interchangeable label) | Approved |
| Botox | Abbvie | Label to include eight new muscles for the treatment of upper limb spasticity in adults | Approved |
| Nucala | Glaxosmithkline | Chronic rhinosinusitis with nasal polyps (Synapse) | Approved |
| Source: Evaluate Pharma & company releases. | |||
| Voluntarily withdrawn accelerated approvals | ||
|---|---|---|
| Product | Company | Withdrawn indication |
| Keytruda | Merck & Co | 3L (PD-L1 ≥1%) gastric/GEJ adenocarcinoma |
| Opdivo | Bristol Myers Squibb | 2L hepatocellular |
| Source: Company releases. | ||
