Upcoming events – US approvals due for Glaxo and Novo Nordisk


Welcome to your weekly digest of approaching regulatory and clinical readouts. December should see a US approval decision for Glaxosmithkline’s HIV combination of dolutegravir plus rilpivirine, which if approved would become the first single-pill doublet for maintenance treatment; however, Gilead is hot on Glaxo’s heels with its new triple combo.

A final US decision for Novo Nordisk’s semaglutide is also due next month. Approval will be vital if the Danish company is to maintain its top position in the diabetes market, and luckily for Novo this looks likely after semaglutide received unanimous adcom backing.

Weapon of choice

Glaxo/Viiv Healthcare filed dolutegravir plus rilpivirine – the latter is the ingredient in Johnson & Johnson’s Edurant – as a single-tablet treatment, which it is hoped could reduce side effects and improve compliance.

The filing was based on two phase III trials, Sword 1 and 2, in which participants were randomised to stay on their combination antiretroviral regimen or to switch to once-daily dolutegravir plus rilpivirine. A pooled analysis found that 95% of patients achieved HIV-1 viral suppression at 48 weeks, and the doublet was non-inferior to three and four-drug regimens (Gilead and Glaxo’s HIV battle intensifies, February 14, 2017)

As HIV patients live longer, minimising the impact of therapy on measures like blood glucose and cholesterol levels has become more important. In the Sword trials the most commonly reported adverse events in the doublet arm were nasopharyngitis, headache, diarrhoea and upper respiratory tract infection, and the overall rate of serious adverse events was comparable between treatment groups.

Glaxo has speeded up the path to approval for dolutegravir plus rilpivirine by using a priority review voucher that it bought for $130m; the seller has never been disclosed. This could put the group two months ahead of Gilead’s single-tablet triplet, bictegravir/F/TAF, which has a PDUFA date in February. 

Triplet therapies are well established in HIV, and Gilead’s latest version has shown non-inferiority – but not superiority – to dolutegravir-containing triplets. 

Potential concerns with a two-drug regimen include the durability of virologic suppression and the risk of a patient developing resistance, so Gilead will be watching to see if the dolutegravir doublet slips up here. 

Gilead’s bictegravir triplet has a 2022 revenue consensus of $5.1bn, according to EvaluatePharma, meaning that it tops the table that year, overtaking Glaxo’s dolutegravir-containing triplet Triumeq.

Top HIV products by 2022
Global indication sales ($bn)
Product Company 2017e 2022e Indication status
Bictegravir/F/TAF (bictegravir-based triple) Gilead Sciences 5.1 Filed
Triumeq (dolutegravir-based triple) Glaxosmithkline 3.2 4.8 Marketed
Genvoya (elvitegravir-based quad) Gilead Sciences 3.6 2.9 Marketed
Tivicay (dolutegravir monotherapy) Glaxosmithkline 1.7 2.5 Marketed
Odefsey (triple) Gilead Sciences 1.1 2.0 Marketed
Source: EvaluatePharma

Growth driver

Meanwhile, Novo’s semaglutide is on track to gain approval by December 5 after an advisory committee voted 16-0 in favour of approval last month.

The once-weekly GLP-1 agonist has the backing of eight phase III trials including the cardiovascular outcomes trial Sustain 6, although the company has previously said that semaglutide will be unlikely to get a cardiovascular benefits claim on its label straight away (Interview – Semaglutide holds the key to Novo’s success, October 3, 2017).

Semaglutide is Novo’s biggest growth driver, with sales set to hit $2.7bn by 2022, according to consensus from EvaluatePharma. It has an NPV of $9bn, or 8% the company’s market cap.

The drug is needed to strengthen the company’s diabetes franchise as its most valuable product, the once daily GLP-1 Victoza, comes under pressure from Lilly’s once-weekly Trulicity. However, in this increasingly competitive sector Novo will have to think carefully about its pricing strategy for semaglutide.

Novo also has an oral version up its sleeve, which is due to yield phase III data next year.

Top-selling GLP-1 agonists in diabetes by 2022
Global indication sales ($m)
Product Company 2017e 2022e Indication status Change in 2022 forecast since Nov 2016
Trulicity Lilly 1,953 3,913 Marketed +32%
Victoza Novo Nordisk 3,240 3,295 Marketed -8%
Semaglutide Novo Nordisk 2,722 Filed +29%
Bydureon Astrazeneca 622 712 Marketed -20%
Semaglutide Oral Novo Nordisk 707 Phase III -3%
Source: EvaluatePharma

To contact the writer of this story email Joanne Fagg in London at joannef@epvantage.com or follow @ByJoFagg on Twitter

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