Physician Views: Recent developments in US diabetes market – impact of safety concerns & emergence of SGLT-2 drug class
With the diabetes market an important therapeutic area for a host of pharmaceutical manufacturers, this week's Physician Views poll will seek feedback from US-based endocrinologists on three key recent developments – discussion regarding pancreatic cancer/pancreatitis risk associated with incretin mimetic diabetes treatments, the role of the FDA in approving new diabetes treatments and the recent launch of Johnson & Johnson's Invokana – the first-in-class SGLT-2 inhibitor.
Last week, the FDA and manufacturers appeared to reach consensus in agreeing that additional data from much larger outcomes studies is required to allay concerns that incretin mimetic treatments are associated with pancreatic risk. The suggestion among analysts is that such sentiment has removed a significant overhang from a number of manufacturers and could help to support increased growth momentum moving into the second half of the year.
Assessing the full impact of these concerns at the physician level remains difficult, but a previous poll run by FirstWord indicates that there has been a moderate increase in caution towards the incretin mimetic therapies. Will endocrinologists be more assured in light of the FDA's measured approach to assessing this risk?
Similarly, this week's poll will also seek to gain further physician feedback regarding the FDA's stance towards diabetes treatments in general – a pertinent issue given a series of recent events; the rejection of Novo Nordisk's Tresiba in February, re-evaluation of Avandia's clinical restrictions at the beginning of June (see Spotlight On: The Avandia legacy and evolution of the FDA’s safety stance) and the administration's aforementioned evaluation of pancreatic risk associated with DPP-4 and GLP-1 treatments.
Lastly, this week's poll will seek to gain additional colour on suggestions – borne from early prescription data trends – that Johnson & Johnson's Invokana is enjoying a stronger than expected launch in the US. Somewhat downplayed by analysts, the SGLT-2 inhibitor class is now rapidly gaining in credibility – an important trend not only for Johnson & Johnson, but a number of other companies developing competing products, such as AstraZeneca/Bristol-Myers Squibb, Eli Lilly/Boehringer Ingelheim and Merck & Co./Pfizer. See ViewPoints: Have analysts undervalued the SGLT-2 diabetes drug class?
Specifically, this week’s FirstWord Physicians View poll will ask US-based endocrinologists:
How their prescribing of DPP-4 and GLP-1 products may shift in light of the FDA’s recent assessment of possible pancreatic risk
What their perception is of the FDA in allowing/preventing access to new diabetes therapies
Whether their initial experience with Johnson & Johnson’s Invokana has matched, exceeded or missed expectation
What factors are driving their use of Invokana
What share of the oral type 2 diabetes market they expect SGLT-2 inhibitors to assumed in two years time