Go or no go? Novo awaits call on oral sema

The Danish group tops the list, while Ardelyx could get its first nod for tenapanor, and Xeris gets a second shot with its hypoglycaemia rescue pen.

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
Tenapanor Ardelyx 12 Sep 1,542
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
Source: EvaluatePharma.

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)
Product Company Description 2018 2020e 2022e 2024e
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
Source: EvaluatePharma.

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.

The application is based on the Cassiopeia trial, which reported last October. Darzalex is already approved first-line in transplant-ineligible patients in various combinations.

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
Product Company Event type  Date
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)
Source: EvaluatePharma.

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