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Panel Meeting For Victoza And Decision Time For Portola’s Anticoagulant

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Welcome to your weekly digest of approaching regulatory and medical readouts. Novo Nordisk’s Victoza will go earlier than a US panel assembly on June 20 with the goal of getting a cardiovascular benefit added to its label. The GLP-1 agonist nonetheless has a much bigger battle on its palms – convincing payers that it is well worth the worth.

And by June 24 Portola (NASDAQ:PTLA) will know the FDA’s determination on betrixaban. A part III trial testing the factor Xa inhibitor’s means to stop blood clots in acute medically ailing patients produced combined results, and with a rejection for an additional of its medicine Portola will need to avoid one other setback.

Cardio profit

An advisory committee will decide on June 20 whether or not Victoza can have cardiovascular safety added to its label, earlier than its PDUFA date in August. In its outcomes trial, Chief, Victoza’s benefit was largely right down to prevention of cardiovascular dying, while no impact was shown on non-fatal strokes or coronary heart attacks (Novo slumps as Leader looks more like a follower, June 14, 2016).

FDA briefing documents released as we speak make it clear that there might be questions over how Victoza met the primary endpoint without displaying a profit on heart attacks and stroke. On the security entrance the FDA notes that long run follow-up is required to characterize the relationship between GLP-1s and the development of pancreatic cancer, a recognized danger issue with the class.

Rivalry in the GLP-1 area is heating up, although Victoza would have the sting with a superiority declare. In its own outcomes trial, Astrazeneca’s Bydureon was shown to be non-inferior to placebo on the composite main endpoint of cardiovascular dying, non-fatal myocardial infarction, or non-fatal stroke – however it did not present superiority. A cardiovascular outcomes research for Lilly’s Trulicity will read out next yr.

Competitors from the SGLT2 inhibitor class is more likely to develop into even stiffer – Lilly and Boehringer’s Jardiance is thus far the one diabetes drug to boast a profit on cardiovascular outcomes on its label. It too was confirmed to stop cardiovascular demise with out vital effect on non-fatal strokes or coronary heart attacks. J&J’s Invokana just lately showed a cardiovascular benefit, however this came with an elevated danger of amputation (ADA – Canvas paints a mixed picture for J&J’s Invokana, June 12, 2017).

Another battle for Victoza shall be convincing payers; it is still barred underneath the nationwide formulary of Categorical Scripts, the most important US pharmacy-benefit supervisor. Getting the cardiovascular declare on its label might persuade payers to start out considering in a different way.

GLP-1 cardiovascular outcomes trial readouts
Product Company Research Standing Trial ID
Lyxumia Sanofi Elixa Met non-inferiority vs placebo NCT01147250
Victoza Novo Nordisk Leader Met superiority vs placebo NCT01179048
Injectable semaglutide Novo Nordisk Maintain 6 Met superiority vs placebo NCT01720446
Bydureon Astrazeneca Exscel Met non-inferiority vs placebo NCT01144338
Oral semaglutide Novo Nordisk Pioneer 6 Main completion Apr 2018 NCT02692716
Trulicity Eli Lilly Rewind Main completion Jul 2018 NCT01394952

Portola’s date with the FDA

Betrixaban is an oral, once-daily issue Xa inhibitor, and the FDA will determine by June 24 whether or not to approve its use to stop blood clots in acutely medically unwell sufferers with associated danger elements.

The venture stumbled by means of its part III research, Apex, failing to point out superiority over the much older drug Lovenox in preventing blood clots in hospitalized patients on the highest danger – these with elevated d-dimer protein – but succeeding within the general research population, including lower-risk patients. Shares fell 30% on the information (Precision medicine takes a scalp as Portola’s results confuse, March 24, 2016).

The corporate released additional analyses two months later reporting improved efficacy when utilizing central d-dimer testing; shares rose 5%. Will probably be troublesome to guess how the FDA will receive the info, however it’s notable that no advisory committee assembly was scheduled.

P-values for main efficacy endpoint* within the Apex research
Utilizing native laboratory d-dimer testing Utilizing central laboratory d-dimer testing
Cohort 1 (patients with elevated d-dimer) zero.054 zero.002
Cohort 2 (patients with elevated d-dimer and aged >75 years) 0.029 0.007
Cohort three (general population) zero.006 zero.006
*Composite of asymptomatic proximal DVT, symptomatic DVT, non-fatal PE, and VTE-related demise by means of Visit three. Supply: NEJM article NCT01583218.

The issue Xa area is dominated by Bayer’s Xarelto and Bristol-Myers Squibb’s Eliquis. Nevertheless, each the large pharma factor Xa drugs have failed to point out any profit in acutely medically ailing sufferers. Betrixaban was capable of beat the standard of care and the corporate could possibly be rueing its choice to concentrate on the slender population.

2022 forecasts sit at $579m, in line with EvaluatePharma consensus, with an NPV of $1.6bn or 77% of Portola’s market cap. It is now Portola’s largest progress driver after the FDA rejected its other venture, Andexxa, an anticoagulant reversal agent, final August.

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