US FDA approval tracker: October 2021

Delays and complete response letters dominated the FDA regulatory scene last month, including a knockback for the troubled pain project tanezumab. After 16 years, and 39 clinical trials, Pfizer and Lilly finally scrapped the whole development programme. Elsewhere, Oncopeptide’s Pepaxto was withdrawn from the US market after the confirmatory Ocean study showed overall survival concerns. The drug had gained accelerated approved for fifth-line multiple myeloma in February. In better news for biopharma, the green light for Roche’s Tecentriq as an adjuvant therapy in NSCLC came early. However, the label restricts Tecentriq’s use to PD-L1-expressing stage II-IIIA patients, and data from the competition looms. Merck & Co’s Keynote-091 trial, testing Keytruda in in stage IB-IIIA patients regardless of PD-L1 expression, is expected to yield data soon.

Notable first-time US approval decisions in October
Project Company Indication(s) 2026e sales by indication ($m) Outcome
Pfizer Atopic dermatitis 1,035 No decision yet
UCB Plaque psoriasis 992 Delayed
(inability to conduct facility inspections because of travel restrictions)
Chemocentryx ANCA-associated vasculitis 610 Approved
DaxibotulinumtoxinA Revance Glabellar lines 430 CRL
(manufacturing deficiencies)
FT218 Avadel Narcolepsy 332 Delayed
(no new date disclosed)
Omeros Haematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA) 298 CRL
(additional data needed)
Novartis 3L chronic myeloid leukaemia 279

Accelerated approval (Philadelphia chromosome-positive CML in chronic phase)

Full approval (with the T315I mutation)

Zimhi Adamis Opioid overdose 64 Approved
(after two CRLs)
Mydcombi Eyenovia Pupil dilation agent 28 CRL
(reclassified as a drug-device combination)
Lilly/Pfizer Osteoarthritis pain 24

CRL (negative adcom in March)

Enzyvant, Sumitomo Dainippon Pharma Paediatric patients with congenital athymia 16 Approved
Oyster Point Dry eye disease Approved
Xipere Bausch Health/
Macular oedema associated with uveitis Approved
Kyzatrex Marius Primary and secondary male hypogonadism No decision yet
(pilocarpine HCl ophthalmic solution 1.25%/
Abbvie Presbyopia (age-related blurry near vision) Approved
Source: Evaluate Pharma & company releases.


Advisory committee meetings in October
Project Company Indication 2026e sales by indication ($m) Outcome
Comirnaty Pfizer/Biontech Covid vaccination in children aged 5-11 2,819 Recommended, given EUA on Oct 29
Spikevax Moderna Booster dose to individuals aged 65 and older, or at high risk owing to medical conditions or occupation 2,756 Recommended
Ad26.COV2-S J&J Booster dose to individuals aged 18 and older 767 Recommended
Pepaxto Oncopeptides In combination with dexamethasone for the treatment of adult patients with r/r multiple myeloma who have received at least four prior lines of therapy  552 Cancelled, Pepaxto withdrawn from US market (had accelerated approval)
Maribavir Takeda Adults with post transplant cytomegalovirus infection/disease 355 Recommended
Source: FDA ad com calendar & Evaluate Pharma.


Supplementary and other notable approval decisions in October
Product Company Indication (clinical trial) Outcome
Tecartus Gilead Adult patients with r/r ALL (Zuma-3) Approved
Dextenza Ocular Therapeutix Ocular itching associated with allergic conjunctivitis Approved
Dupixent Sanofi/
Asthma in ages 6-11 (Voyage) Approved
(Lucentis port delivery system)
Roche Wet AMD (Archway) Approved
Cortrophin Gel ANI Multiple sclerosis, rheumatoid arthritis, and nephrotic syndrome Approved
Verzenio Lilly HR+ Her2- high risk early breast cancer (monarchE) Approved
Keytruda Merck & Co 1L cervical cancer plus chemo (whose tumours express PD-L1) also 2L as a single agent (Keynote-826) Approved
(2L converted to full approval from accelerated approval)
Tecentriq Roche Adjuvant treatment for adults with Stage II-IIIA NSCLC whose tumours express PD-L1≥1% (Impower-010) Approved (~6 weeks early)
Biktarvy Gilead Low-dose tablet for HIV treatment in virologically suppressed children weighing at least 14 kg (Cohort 3) Approved
Cyltezo (Humira biosimilar) Boehringer Ingelheim RA, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis, plaque psoriasis, polyarticular juvenile idiopathic arthritis Approved as interchangeable biosimilar
Tyvaso DPI Mannkind/United Therapeutics PAH and pulmonary hypertension associated with interstitial lung disease (Breeze) CRL
(deficiencies at contract manufacturer)
Myring Mayne Pharma/
Generic contraceptive ring CRL
(additional data)
Andexxa Astrazeneca Addition of edoxaban and enoxaparin (FXa inhibitors) to the label CRL
Xeljanz Pfizer Ankylosing spondylitis (A3921120) No decision yet
Olumiant Lilly Atopic dermatitis (Breeze-AD program) No decision yet
Rinvoq Abbvie Atopic dermatitis, psoriatic arthritis and ankylosing spondylitis No decision yet
Source: Evaluate Pharma & company releases.

This story has been updated to include Andexxa's CRL, as noted in Astrazeneca's third quarter release.


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