August was a big month for approvals – and rejections – from the US FDA. Further important decisions due in September could make or break several companies’ years.
Top of the list is the diabetes specialist Novo Nordisk, which is waiting to see whether it will get the go-ahead for the once-daily oral version of its GLP1 agonist semaglutide in type 2 diabetes. The project is expected to become the group’s second-biggest growth driver, with $3.2bn in sales in 2024, according to EvaluatePharma sellside consensus.
|Notable first-time US approval decisions due in September|
|Project||Company||PDUFA date||Product NPV ($m)|
|Gvoke HypoPen||Xeris Pharmaceuticals||10 Sep||739|
|Oral semaglutide||Novo Nordisk||20 Sep (estimate)||2,559|
|Valtoco||Neurelis||25 Sep (estimate)||-|
|Imvamune (MVA-BN)||Bavarian Nordic||Sep 2019||1,274|
|Nordimet (methotrexate)||Cumberland Pharmaceuticals||Sep 2019||21|
Novo used a priority review voucher to hasten a decision on oral sema, and approval looks odds-on after positive results from the huge Pioneer programme. There is still the question of whether the project can get a cardiovascular benefit on its label, although a decision here is not due until January under standard 10-month review (Novo’s next big diabetes bet heads to regulators, 26 November 2018).
Assuming oral sema does get the nod, the next talking point will be its price. Novo will want to drive uptake without too much cannibalisation of its existing injectable GLP1 franchise; the company hopes that the convenience of an oral pill could help expand the market. Bernstein analysts have suggested an oral sema list price of $20-22 per day, slightly lower than the $25 of Novo’s once-weekly injectable, Ozempic, and Lilly’s rival product Trulicity.
As things stand, Trulicity is still expected to be the top type 2 diabetes drug in 2024, but things might change as the oral sema launch progresses.
|Top five type 2 diabetes drugs in 2024|
|Annual sales ($m)|
|Trulicity||Lilly||Once-weekly injectable GLP1 agonist||3,199||5,052||6,269||7,125|
|Ozempic||Novo Nordisk||Once-weekly injectable GLP1 agonist||285||2,054||3,709||4,432|
|Oral semaglutide||Novo Nordisk||Once-daily oral GLP1 agonist||-||387||1,721||3,230|
|Jardiance||Boehringer Ingelheim/Lilly||Once-daily oral SGLT2 inhibitor||1,726||2,221||2,794||3,192|
|Farxiga||Astrazeneca||Once-daily oral SGLT2 inhibitor||1,316||1,890||2,278||2,385|
Meanwhile, Ardelyx also faces a big decision with its lead asset, tenapanor, in constipation-predominant irritable bowel syndrome (IBS-C).
The project is expected to get the green light after its phase III T3MPO-1 and T3MPO-2 trials met primary endpoints (T3MPO change for Ardelyx, 12 October 2017). However, with tenapanor not looking any better than Allergan’s marketed constipation drug Linzess, the smaller group could struggle commercially, particularly once Allergan becomes part of Abbvie.
Whether Ardelyx succeeds here could depend on it hooking a partner, but none has emerged so far. Tenapanor is also being studied in other indications, including hyperphosphataemia in end-stage renal disease, with phase III data due this year.
Xeris will hope that it is second time lucky for its Gvoke glucagon pen, designed to treat diabetics suffering from hypoglycaemia. The project was originally due an approval decision in June before being pushed back by three months to allow the FDA to address manufacturing questions.
Xeris also has a big rival in the shape of Lilly, which got the go-ahead for its glucagon nasal spray Baqsimi in July. Despite the competition, Leerink analysts believe that Gvoke could capture 30% of the market.
Several groups have potential label expansions for marketed products, but the most eagerly awaited, for Amarin’s Vascepa, has been delayed after the FDA scheduled an adcom at the eleventh hour. It had originally been due by 27 September.
Meanwhile, Boehringer Ingelheim’s idiopathic pulmonary fibrosis drug Ofev could become the first approved therapy in the US for another fibrotic disorder, systemic sclerosis-associated interstitial lung disease, after an FDA panel came down 10-7 in its favour in July.
And Johnson & Johnson/Genmab’s Darzalex could soon be approved as part of yet another combo in first-line multiple myeloma: this time, alongside Velcade, thalidomide and dexamethasone in patients eligible for autologous stem cell transplant.
Another supplemental approval decision will involve J&J, whose SGLT2 inhibitor Invokana could get the nod for reducing cardiorenal events in patients with type 2 diabetes and chronic kidney disease, following its win in the Credence study (ISN 2019 – Kidney benefit could help Invokana compete again, April 15, 2019).
If approved, Invokana would break new ground for diabetes drugs, but J&J’s SGLT2 rivals also have their eye on this market, with Astrazeneca’s Farxiga and Lilly/Boehringer’s Jardiance already in trials in kidney disease patients, both with and without diabetes.
|Supplementary and other notable approval decisions due in September|
|Tecentriq||Roche||sBLA for 1L NSCLC (plus Abraxane and carboplatin)||Sep 2|
|Ofev||Boehringer Ingelheim||sNDA for systemic sclerosis-associated interstitial lung disease||Sep 18 (estimate)|
|Nucala||Glaxosmithkline||sBLA as add-on treatment for eosinophilic asthma in pts aged 6-11||Sep 19 (estimate)|
|Pifeltro||Merck & Co||sNDA for HIV-1 pts switching from stable antiretroviral regimen||Sep 20|
|Delstrigo||Merck & Co||sNDA for HIV-1 pts switching from stable antiretroviral regimen||Sep 20|
|Darzalex||Johnson & Johnson/Genmab||sBLA for 1L MM pts eligible for stem cell transplant (plus Velcade, thalidomide, dexamethasone)||Sep 26|
|Invokana||Johnson & Johnson||sNDA for chronic kidney disease in type 2 diabetics||Sep 27 (estimate)|