Go or no go? Abbvie, Roche and Kala await key decisions

One of the biggest drugs of the year, Abbvie’s Jak inhibitor upadacitinib, could get the nod in August.

After a quiet couple of months the US FDA has a busy August ahead. The agency is set to make approval decisions on up to 11 new projects, according to Vantage’s monthly PDUFA analysis.

The most important of these could concern Abbvie’s rheumatoid arthritis contender upadacitinib. Meanwhile, Roche will be hoping to justify its purchase of Ignyta with a nod for entrectinib, and Kala could get the go-ahead for its lead pipeline asset, the dry eye project KPI-121.

Notable first-time US approval decisions due in August
Project Company PDUFA date Product NPV ($m)
Pexidartinib  Daiichi Sankyo Aug 3 553
Wakix (pitolisant) Harmony Biosciences Aug 12 (estimate) -
KPI-121 Kala Pharmaceuticals Aug 15 1,571
Rozlytrek Roche Aug 18 1,034
Golodirsen Sarepta Aug 19 703
Lefamulin Nabriva Therapeutics Aug 19 444*
Upadacitinib  Abbvie Aug 20 (estimate) 10,495
Nouriast Kyowa Kirin Aug 27 212
Rexista/Oxycodone ER Intellipharmaceutics Aug 28 112
NKTR-181 Nektar Therapeutics Aug 29 518
Pretomanid Mylan/TB Alliance Aug (unspecified) -
*Includes oral and IV versions. Source: EvaluatePharma.

Abbvie, which previously only disclosed that a verdict on upadacitinib was due in the third quarter, said during today’s earnings call that the FDA should make its decision “in the coming weeks”.

The Jak inhibitor’s sales are forecast to reach $2.5bn by 2024, according to EvaluatePharma sellside consensus, putting it just behind another new Abbvie product, Skyrizi, which got off to an unexpectedly good start in the second quarter (Novel drug approvals head for a down year, July 19, 2019). 

The company needs all the help it can get as it braces for US biosimilar competition to Humira, set to hit in 2023. As well as going up against existing RA therapies, upadacitinib could also soon face another selective Jak inhibitor, Galapagos and Gilead’s filgotinib.

Of the other big August decisions, Roche looks likely to get the go-ahead for its targeted project entrectinib, now known as Rozlytrek, in NTRK fusion-positive tumours and Ros1-positive non-small cell lung cancer. The product got the nod in Japan in June.

Daiichi has a good shot at getting the thumbs up for its rare tumour candidate pexidartinib after a positive FDA ad com in May. Still, the Japanese company has already received a rejection for a related oncology project, quizartinib, which had also been set for a decision in August.

And Sarepta is expected to get approval for its latest exon-skipping Duchenne muscular dystrophy project, golodirsen; however, the asset has been overshadowed by increasing excitement around the company’s gene therapies.

Meanwhile, Kala has a lot riding on KPI-121, but approval is in doubt given mixed results from its pivotal trials. The company hopes to address the inconsistencies in the data with a new study, Stride-3, but this is not due to yield results until the fourth quarter.

Opioid doubts

And things do not look rosy for Nektar and Intellipharmaceutics International. This week the FDA cancelled panels to discuss opioid painkillers, including the companies’ respective projects NKTR-181 and Oxycodone ER, raising doubts about whether the agency would be able to make a decision on these assets in August as scheduled.

Nektar shares fell 7% yesterday, although hopes had not been high for NKTR-181, and the company spun the project out in May to focus on its cancer candidates.

Of the potential supplementary approvals, Vanda Pharmaceuticals’ Hetlioz looks unlikely to get an expanded label for jetlag disorder after the FDA highlighted deficiencies in the application earlier this week.

Still, expectations were not high in jetlag. The big hope for the product, which is already approved for non-24-hour sleep wake disorder, is Smith-Magenis syndrome, where Vanda plans to file for US approval in the third quarter after posting mixed data in December.

Supplementary and other notable approval decisions due in August
Product Company Event type Date
Hetlioz Vanda Pharmaceuticals sNDA for jet lag disorder Aug 16
Sodium thiosulfate injection Hope Pharmaceuticals sNDA for chemotherapy-induced side effects Q3 2019 (estimate)
Source: EvaluatePharma.

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