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.

Notable first-time US approval decisions in September

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. 

 

Supplementary and other notable approval decisions in September

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

*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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