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 Elsewhere, Oncopeptide’s Pepaxto was withdrawn from the US market after the confirmatory Ocean study showed overall survival concerns.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 ($m) | Outcome |
| Cibinqo (abrocitinib) |
Pfizer | Atopic dermatitis | 1,035 | No decision yet |
| Bimzelx (bimekizumab) |
UCB | Plaque psoriasis | 992 | Delayed (inability to conduct facility inspections because of travel restrictions) |
| Vynpenta (avacopan) |
Chemocentryx | ANCA-associated vasculitis | 610 | Approved |
| DaxibotulinumtoxinA | Revance | Glabellar lines | 430 | CRL (manufacturing deficiencies) |
| FT218 | Avadel | Narcolepsy | 332 | Delayed (no new date disclosed) |
| Narsoplimab (OMS721) |
Omeros | Haematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA) | 298 | CRL (additional data needed) |
| Scemblix (asciminib) |
Novartis | 3L chronic myeloid leukaemia | 279 |
Accelerated approval (Philadelphia chromosome-positive CML in chronic phase) Full approval (with the T315I mutation) |
| Zimhi | Adamis | Opioid overdose | 64 | Approved (after two CRLs) |
| Mydcombi | Eyenovia | Pupil dilation agent | 28 | CRL (reclassified as a drug-device combination) |
| Raylumis (tanezumab) |
Lilly/Pfizer | Osteoarthritis pain | 24 |
CRL (negative adcom in March) |
| Rethymic (RVT-802) |
Enzyvant, Sumitomo Dainippon Pharma | Paediatric patients with congenital athymia | 16 | Approved |
| Tyrvaya (OC-01) |
Oyster Point | Dry eye disease | – | Approved |
| Xipere | Bausch Health/ Clearside |
Macular oedema associated with uveitis | – | Approved |
| Kyzatrex | Marius | Primary and secondary male hypogonadism | – | No decision yet |
| Vuity (pilocarpine HCl ophthalmic solution 1.25%/ AGN-190584) |
Abbvie | Presbyopia (age-related blurry near vision) | – | Approved |
| Source: Evaluate Pharma & company releases. | ||||
| Advisory committee meetings in October | ||||
|---|---|---|---|---|
| Project | Company | Indication | 2026e sales by indication ($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/ Regeneron |
Asthma in ages 6-11 (Voyage) | Approved |
| Susvimo (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/ Mithra |
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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