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 However, the drug's accelerated approval in third-line gastric cancer was voluntarily withdrawn following an FDA-backed panel meeting in April.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
Bayer CKD and type 2 diabetes 896 Approved
Rezurock (belumosudil/
Kadmon Chronic graft vs host disease 863 Approved (~6wks early)
Merck & Co/Ligand Pneumococcal infection vaccine (adults) 786 Approved
Ibsrela (tenapanor) Ardelyx Control of serum phosphorus in adult patients with CKD 701 CRL
Chemocentryx ANCA-associated vasculitis  639 Delayed to October 7
Saphnelo (anifrolumab) Astrazeneca Moderate to severe SLE 488 Approved
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
Provention Bio Delay or prevention of type 1 diabetes in at-risk individuals - CRL
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
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.

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