Upcoming events: US approvals in rheumatoid arthritis and pulmonary arterial hypertension

Welcome to your weekly digest of approaching regulatory events and clinical readouts. An FDA decision on subcutaneous Actemra is expected this month, alongside two decisions on pulmonary arterial hypertension candidates from Bayer and Actelion. However, with the US government shutdown under way several October PDUFAs could be delayed.

Intravenous Actemra is on the market for rheumatoid arthritis. Looking to improve dosing convenience, Roche has submitted a subcutaneous version to US regulator. However, this is coming late to the game, with subcutaneous Humira leading the market, and oral therapies now in the mix.

Meanwhile, Bayer’s Adempas received a unanimous recommendation from an advisory committee in pulmonary arterial hypertension (PAH) and chronic thromboembolic pulmonary hypertension (CTEPH). While Adempas would be the only non-surgical option for CTEPH, the PAH market is increasingly crowded. Alongside generics, competition comes from Actelion’s Opsumit, which thanks to a mortality benefit is forecast to lead the market in 2018, according to EvaluatePharma.

Roche: Actemra SC

Intravenous Actemra was approved in 2010 and is indicated for rheumatoid arthritis, polyarticular juvenile idiopathic arthritis and systemic juvenile idiopathic arthritis. It is Roche's fourth-largest growth driver. Worldwide sales last year were $898m when revenues booked by partner Chugai Pharmaceutical are included; sales in 2018 are expected to reach $2.3bn, according to EvaluatePharma.

The submission for subcutaneous Actemra is based on two phase III studies called Summacta and Brevacta. Both trials involved patients with moderate to severe, active rheumatoid arthritis who had an inadequate response to disease-modifying anti-rheumatic drugs.

In the Summacta study the subcutaneous formulation showed non-inferiority to intravenous Actemra, while in Brevacta the primary endpoint was achieved, with significantly more patients on treatment showing an ACR20 response at week 24 than those taking a placebo. Adverse events were comparable between subcutaneous and intravenous groups.

Intravenous Actemra has struggled to carve out market share against the dominant anti-TNF therapies, such as Humira. Even with its head-to-head win against Humira the administration route has impeded sales (Roche scores important win for Actemra, March 2, 2012). The introduction of oral therapies such as Pfizer’s Xeljanz means the space is getting more competitive.

Analysts note that approval of subcutaneous Actemra will help boost sales growth, because after its approval patients will switch; however, they are not forecasting how much sales will grow, and without forecasts it is a game of wait and see. Roche will be hoping for rapid switch over, as the patent for the intravenous version looks to expire in 2019, according to EvaluatePharma.

Bayer's Adempas and Actelion's Opsumit

Adempas is Bayer’s fourth-largest growth driver, with 2018 sales forecast to reach $669m, according to EvaluatePharmaconsensus. The drug has been given orphan drug designation for both PAH and CTEPH, and approval is expected by October 11.

The PAH space is increasingly crowded; the current market leader, Actelion’s Tracleer, had worldwide sales of $1.6bn in this indication last year. Its patent is set to expire in 2015, and sales are forecast to tumble to $288m in 2018 as generics enter.

For CTEPH there is no approved non-surgical option, offering a better market opportunity for Adempas (Upcoming events: US advisory panels to deliberate Samsca and riociguat, August 1, 2013).

Opsumit, known generically as macitentan, did not undergo an adcom, and analysts at UBS are confident that it will be approved by October 18 or 19. Credit Suisse analysts write that Opsumit will likely capture the majority of new patients because it has demonstrated a mortality benefit in PAH, a significant advantage over Adempas, which will be judged on its six-minute walk test data.

Opsumit is Actelion’s leading growth driver, with 2018 sales expected to reach $961m, according to EvaluatePharma. The focus will be on how much of Tracleer’s revenues can be replaced by Opsumit before widespread generic versions of Tracleer enter.

Trial ID
Summacta NCT01194414 
Brevacta NCT01232569

All information is sourced to analyst notes and the EvaluatePharma Calendar of Events tool.

To contact the writer of this story email Joanne Fagg in London at [email protected] or follow @JoEPVantage on Twitter

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