US FDA approval tracker: May 2022
The most valuable approval of the year was bestowed in May − that of Lilly’s Mounjaro in type 2 diabetes. According to Evaluate Pharma its consensus 2028 forecasts are over $8bn, and the product is gearing up to take market share from Novo’s diabetes franchise. Elsewhere it was good news for Dupixent as the anti-IL-4/1L-13 MAb became the first FDA-approved drug for the chronic inflammatory disease eosinophilic oesophagitis (EoE). The decision for Sanofi/Regeneron’s product came over two months early. Competing data from Astrazeneca’s phase 3 Messina study testing the anti-IL-5 MAb Fasenra in EoE are expected in the second half of the year. It was not all good news last month: UCB and Verrica both received knockbacks, while Avadel, Amicus and Pfizer/Myovant all had their Pdufas extended. On the theme of delays, TG Therapeutics became the latest to suffer a three-month extension, announcing yesterday that the Pdufa for ublituximab in relapsing multiple sclerosis had been pushed out to the end of December. This came after a long list of setbacks for the company.
| Notable first-time US approval decisions in May | ||||
|---|---|---|---|---|
| Project | Company | Indication(s) | 2028e sales by indication (SBI) ($m) | Outcome |
| Mounjaro (tirzepatide) |
Lilly | Type 2 diabetes | 8,132 | Approved |
| Bimzelx | UCB | Plaque psoriasis | 1,191 | CRL (pre-approval inspections) |
| AXS-05 | Axsome | Major depressive disorder | 787 | Pending (Q2) |
| FT218 | Avadel | Treatment of excessive daytime sleepiness or cataplexy in adults with narcolepsy | 361 | Full approval not expected until mid-2023, when Jazz's '963 REMS patent expires |
| VP-102 | Verrica | Molluscum contagiosum | 359 | CRL (deficiencies at CMO) |
| Miglustat | Amicus | Pompe disease | 266* | Delayed to Aug 29 (cipaglucosidase Pdufa also delayed to Oct 29, combination product known as AT-GAA) |
| Vtama (tapinarof) | Dermavant | Plaque psoriasis | - | Approved |
| Annik (penpulimab) | Akeso/Sino | 3L nasopharyngeal carcinoma | - | Pending (H1) |
| Voquenza triple pak, Voquenza dual pak (vonoprazan) |
Phathom | Adults with H pylori infection | - | Approved |
| Radicava ORS (MT-1186, oral edaravone) | Mitsubishi Tanabe | ALS | - | Approved |
| Lamotrigine (ET-105) for supspension | Eton/Azurity | Epilepsy | - | CRL |
| *Forecasts for AT-GAA. Source: Evaluate Pharma & company releases. | ||||
| Supplementary and other notable approval decisions in May | |||
|---|---|---|---|
| Product | Company | Indication (clinical trial) | Outcome |
| Myfembree | Pfizer/Myovant | Moderate to severe pain associated with endometriosis (Spirit 1, Spirit 2) | Delayed to Aug 6 (FDA needs more time to review bone mineral density information) |
| Tyvaso DPI | Mannkind/United Therapeutics | PAH and pulmonary hypertension-associated interstitial lung disease | Approved |
| Evrysdi | Roche/PTC | Pre-symptomatic infants under 2 months old with spinal muscular atrophy (Rainbowfish) | Approved |
| Opdivo + Yervoy, Opdivo + chemo | Bristol Myers Squibb | 1L unresected advanced, recurrent or metastatic oesophageal squamous cell carcinoma (Checkmate-648) | Approved |
| Enhertu | Astra/Daiichi | Her2+ve breast cancer after anti-Her2-therapy (Destiny-Breast 03) | Approved |
| Olumiant | Lilly | Treatment of certain hospitalised patients with Covid-19 | Approved |
| Kymriah | Novartis | 3L follicular lymphoma (ph2 Elara) | Approved |
| Tpoxx IV | Siga | Smallpox | Approved |
| Dupixent | Sanofi/Regeneron | Eosinophilic oesophagitis, 12 years and older (NCT03633617) | Approved (over 2mth early) |
| Annovera | Therapeutics MD | Birth control, revisions to in vitro release testing specification | Approved |
| Vidaza | Bristol Myers Squibb | Paediatric patients with newly diagnosed juvenile myelomonocytic leukaemia (AZA-JMML-001) | Approved |
| Tibsovo + Vidaza | Servier | Newly diagnosed IDH1-mutated AML in adults 75 years or older (Agile) | Approved |
| Fylnetra (Neulasta biosimilar) |
Amneal | Neutropenia | Approved |
| Beovu | Novartis | Diabetic macular oedema (Kestrel, Kite) | Approved |
| Source: Evaluate Pharma & company releases. | |||
| FDA Covid-19 EUAs | ||
|---|---|---|
| Product | Company | Outcome |
| Janssen Covid-19 vaccine (Ad26.COV2-S) |
J&J | Authorised use limited to individuals aged 18+ for whom other authorised or approved vaccines are not accessible or clinically appropriate, and to individuals aged 18+ who elect to receive the J&J vaccine because they would otherwise not receive a vaccine (received EUA in Feb 21) |
| Comirnaty | Pfizer/ Biontech |
Single booster dose authorised for individuals aged 5-11 |
| Source: company releases. | ||
The supplementary table has been updated to include Beovu's approval.
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