Friday Five – This week’s key news stories

A lower than expected price for Aimovig

Late last week, the FDA approved Amgen and Novartis' Aimovig; the first in a new class of agents (CGRP inhibitors) designed to prevent migraine.

Aimovig has been priced lower in the US than most had anticipated; the upshot of multiple factors. Lower launch prices for novel therapies are becoming more commonplace (see also Roche's Ocrevus in multiple sclerosis), while Amgen has learnt from experience - despite an elegant mechanism of action and clear clinical benefit, its PCSK9 inhibitor Repatha has struggled to gain traction due to onerous payer restrictions.

In this particular case, pending competition from other CGRP inhibitors is also a prominent factor in Amgen and Novartis' thinking; Amgen's commercial operations head Tony Hooper conceded as much, suggesting the strategy is designed to boost early adoption and provide "no reason for satisfied patients to change therapy," once competitors reach the market.

Keytruda and Imfinzi the IO winners in lung cancer

As we head towards the ASCO annual meeting in two weeks' time, has Merck & Co. locked up most of the first-line metastatic non-small-cell lung cancer (NSCLC) market for its PD-1 inhibitor Keytruda?

It is looking increasingly likely; on Wednesday it confirmed a study assessing the combination of Keytruda and chemotherapy in squamous patients met survival endpoints regardless of PD-L1 expression level. Detailed results will be presented at ASCO.

Keytruda's dominance of this market makes AstraZeneca's bid to carve out a niche for its PD-L1 inhibitor Imfinzi in Stage III NSCLC all the more important. Presenting its first-quarter results late last week, AstraZeneca appears to be seeing commercial progress on this front.

Clinical evidence builds in favour of Hemlibra

The haemophilia market could be poised for significant change over the next decade and Roche's Hemlibra is a near-term disruptor. Approved last year for haemophilia A in patients who have developed inhibitors to Factor VIII replacement therapies, Hemlibra looks to be potentially practice changing as a treatment for the much larger population of patients who are eligible to receive Factor VIII therapies. Data presented from the Phase III HAVEN 3 and 4 studies this week attests to this, with the latter also raising the potential of once-monthly dosing.

Some safety concerns will likely slow adoption of Hemlibra in what is acknowledged as a disease area where physicians are conservative towards new therapies. That said, impressive efficacy data for Hemlibra continues to at least partly frame questions around the strategic rationale for Takeda's pending acquisition of Shire and Sanofi's purchase of Bioverativ; both deals push the respective buyers into the haemophilia market when it could be on the cusp of significant evolution.

The FDA mobilises on gene therapy regulation

This extends to potential 'one time' gene therapies, with Spark Therapeutics and BioMarin Pharmaceutical presenting new data for their investigative haemophilia B and haemophilia A products, respectively, this week. Both approaches work - and look increasingly approvable - though questions remain over long-term durability that can only be answered in time.

On a related note, FDA commissioner Scott Gottlieb announced this week that the agency will shortly release a framework addressing manufacturing issues and the development pathway for gene therapies, including potential accelerated approval endpoints for certain products. Initial focus will be on haemophilia treatments. Gottlieb added that the agency has received 500 active investigational new drug applications for gene therapies including 100 in the last year alone. He also cited an MIT report suggesting 40 gene therapies could be commercially available by 2022.   

Don't write anti-NGFs off again, says expert

There should still be a role for anti-NGF biologics being developed for osteoarthritis and chronic lower back pain - among other pain-related indications - despite recent confirmation that Regeneron and Teva have abandoned studies looking at higher doses of the agent fasinumab on safety grounds, a key opinion leader (KOL) told FirstWord this week.

This view prevails despite the FDA issuing multiple clinical holds to monoclonal antibodies targeting NGF over the years, with the KOL in question also confident that lower-dose regimens will deliver the type of compelling efficacy data that has prompted persistent development efforts.

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