The US Food and Drug Administration’s announcement of a broad review into the safety profile of attention-deficit hyperactivity disorder treatments is going to boost the prospects for Shire’s new drug Vyvanse.

That is the view of Navid Malik, an analyst at Collins Stewart, who noted that “generally speaking, the FDA has requested that a black box warning be added to the label of a number of drugs currently used in ADHD. These relate to psychiatric issues [Eli Lilly's Strattera (atomoxetine)] and increased risks of heart attack and increased blood pressure [Shire’s own Adderall XR (mixed amphetamine salts) and Novartis Ritalin (methylphenidate)].

Whilst these risks have been highlighted previously by the US regulators, Mr Malik noted that this update from the FDA is the strongest yet in terms of signalling to physicians, that they need to carefully vet (when prescribing) and regulate patients who are on these medicines.

However, the analyst claims that one of the positives coming from the agency’s review is the potential for Shire to differentiate Vyvanse (lisdexamfetamine dimesylate), its new ADHD drug. The company agreed earlier this week to buy New River Pharmaceuticals of the USA for $2.6 billion in a deal that would give it full control of the treatment.

According to Mr Malik, the reasons for this relate to the fact that Vyvanse has so far demonstrated a relatively clean cardiovascular safety profile in Phase III trials and given the fact that Shire needs to switch its Adderall XR franchise into Vyvanse, ahead of generic entry for the former, due in April 2009, “this safety advantage can only be a positive.” FDA approval for Vyvanse is expected in the next few days and the drug is expected to generate substantial sales in excess of $1 billion.

Fosrenol launched in the UK

Meantime, Shire has announced the UK launch of Fosrenol (lanthanum carbonate) following the product's authorisation as a phosphate binding agent for use in the control of hyperphosphataemia in chronic renal failure

patients on haemodialysis or continuous ambulatory peritoneal dialysis


The firm said that Fosrenol, an effective non-calcium phosphate binder, is well-tolerated in the majority of patients who “can be managed with one chewable tablet during each meal.” The drug was launched in the USA in 2005 and is also available in Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Iceland, Ireland, The Netherlands, Poland and Sweden.