US FDA approvals tracker: September
The biggest approval of last month was Novo’s oral semaglutide, now branded Rybelsus; however, questions remain over its price tag and whether it can get a label for cardiovascular risk reduction (Pricing questions remain as Novo gets the nod for oral sema, September 23, 2019). Meanwhile Ardelyx gained its first ever approval with Ibsrela in constipation-predominant irritable bowel syndrome, but the product’s commercial chances could depend on Ardelyx hooking a partner. The US FDA also had a busy month for supplementary approvals. Notably Johnson & Johnson’s Invokana became the first SGLT2 inhibitor approved for reducing cardiorenal events in patients with type 2 diabetes and chronic kidney disease, based on the Credence study. However, Roche’s Tecentriq will have to wait a bit longer, with its decision in first-line NSCLC delayed until December.
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Notable first-time US approval decisions in September |
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|---|---|---|---|
|
Project |
Company |
Product NPV ($m)* |
Outcome |
| Rybelsus (oral semaglutide) | Novo Nordisk | 5,126 | Approved |
| Ibsrela (tenapanor) | Ardelyx | 1,593 | Approved |
| Jynneos (Imvamune/MVA-BN) | Bavarian Nordic | 1,276 | Approved |
| Gvoke HypoPen | Xeris Pharmaceuticals | 664 | Approved |
| Valtoco | Neurelis | - | No decision yet |
| *NPV data as of September 30, EvaluatePharma. Source: Go or no go? Novo awaits call on oral sema, August 30, 2019. | |||
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Supplementary and other notable approval decisions in September |
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|---|---|---|---|
|
Product |
Company |
Event type |
Outcome |
|
Tecentriq |
Roche |
sBLA for 1L NSCLC (plus Abraxane and carboplatin) |
Delayed to December 2 |
|
Ofev |
Boehringer Ingelheim |
sNDA for systemic sclerosis-associated interstitial lung disease |
Approved |
|
Nucala |
Glaxosmithkline |
sBLA as add-on treatment for eosinophilic asthma in pts aged 6-11 |
Approved |
|
Pifeltro |
Merck & Co |
sNDA for HIV-1 pts switching from stable antiretroviral regimen |
Approved |
|
Delstrigo |
Merck & Co |
sNDA for HIV-1 pts switching from stable antiretroviral regimen |
Approved |
|
Darzalex |
Johnson & Johnson/Genmab |
sBLA for 1L MM pts eligible for stem cell transplant (plus Velcade, thalidomide, dexamethasone) |
Approved |
|
Invokana |
Johnson & Johnson |
sNDA for chronic kidney disease in type 2 diabetics |
Approved |
|
Keytruda + Lenvima* |
Merck & Co, Eisai |
sBLA for endometrial carcinoma that is not microsatellite instability-high or mismatch repair deficient |
Approved |
|
Erleada* |
Johnson & Johnson |
sNDA in metastatic castration-sensitive prostate cancer |
Approved |
|
Mavyret* |
Abbvie |
sNDA for eight-week treatment for adults and children with all genotypes of hepatitis C |
Approved |
|
Rituxan* |
Roche |
sBLA for granulomatosis with polyangiitis and microscopic polyangiitis in children two years of age and older |
Approved |
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*Extra approvals not noted in August story. Source: Go or no go? Novo awaits call on oral sema, August 30, 2019. |
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