FDA approves Accrufer, a novel oral option for iron deficiency anemia in adults

Written by Dr. Kamal Kant Kohli Kohli Published On 2019-07-29T19:15:58+05:30 | Updated On 11 Aug 2021 4:05 PM IST

FDA approves Accrufer, a novel oral option for iron deficiency anemia in adults.

The Food and Drug Administration (FDA) has approved Accrufer (ferric maltol; Shield Therapeutics) for the treatment of iron deficiency in adults. Accrufer is supplied in a capsule formulation containing 30mg of iron, as ferric maltol.

Prior to approval by Food and Drug Administration, Accrufer is already approved in both the European Union and Switzerland for the treatment of iron deficiency in adults.

Accrufer is a novel, stable, non-salt based oral treatment for adults with iron deficiency with or that has been shown to be an efficacious and well-tolerated therapy in a range of controlled phase 3 trials. This trial in a way paved path for approval by Food and Drug Administration.

Following the recently announced positive results of the Phase IIIb AEGIS-H2H study in which Feraccru® demonstrated it was non-inferior to intravenously-administered Ferinject® at delivering improvements in haemoglobin levels without requiring hospital-based administration,Accrufer offers a compelling alternative to IV Iron for those patients that cannot tolerate salt-based oral iron therapies and wish to avoid the complexities of infusion-based

therapies.

The WHO state that iron deficiency is the most common and widespread nutritional disorder in the world. As well as affecting a large number of children and women in non-industrialized countries, it is the only nutrient deficiency which is also significantly prevalent in virtually all industrialized nations.

With this broad label approval Accrufer® (as the product will be marketed in the USA) has taken a big step towards exploiting the very large commercial opportunity in the USA, the world's largest and most attractively reimbursed pharmaceutical market. Market research suggests that the prescription market for iron replacement therapy in the USA is worth over $1.0bn annually. There are between 8 million and 9 million patients in the USA who suffer from iron deficiency anaemia and management estimate potentially two to three times this number require treatment for iron deficiency.

Accrufer®'s confirmed efficacy, together with its good tolerability and mode of absorption - by which the body absorbs only as much iron from Accrufer as it needs - means that the product could be the ideal choice for iron deficient patients who cannot tolerate salt-based oral iron alternatives. These features, combined with the non-

inferiority results from the AEGIS-H2H study announced in March 2019, mean that treatment with Accrufer® might

remove the need for patients to progress to intravenous iron therapy, leading to a change in the current paradigm

for the treatment of iron deficiency anaemia.

Carl Sterritt, CEO of Shield Therapeutics: "We are delighted that the FDA has approved the new drug application

for our lead asset. This is a further major milestone for the Company which we have worked tirelessly to achieve,

and I am very proud to lead the team within Shield that has made this happen. With this broad approval and IP

protection out to 2035, Feraccru®/ Accrufer® has a real and very attractive long-term market opportunity to exploit

in the USA. We have been pleased with the levels of interest and engagement shown by 3rd parties in commercialising Accrufer® in the USA and we look forward to finalising these discussions and appointing a commercial partner In the world's most attractive pharmaceutical market,so that more patients with iron deficiency can benefit from treatment with Accrufer® at the earliest opportunity."

Jackie Mitchell, VP Regulatory Affairs of Shield Therapeutics: "The broad label that the FDA has granted provides

a very strong signal as to the tolerability and efficacy profile of Feraccru®/ Accrufer and provides a novel and

convenient treatment alternative to the millions of US patients who routinely suffer with iron deficiency. We believe

that this broad approval, together with the recent clinical trial data on Feraccru® that showed it to be non-inferior in treatment effect to Ferinject®/ Injectafer®, the leading IV iron therapy, can lead to a change in the current

paradigm for the treatment iron deficiency anaemia."

When salt-based oral iron therapies are ingested they can cause a range of mild-to-severe gastrointestinal tract (GI)

adverse events, including nausea, bloating and constipation. These lead to poor tolerability, reduced patient

compliance and ultimately treatment failure. Accrufer is not an iron salt; iron can be absorbed from the ferric maltol molecule and, as a result, it does not routinely cause the same treatment-limiting intolerance issues.

Prior to Accrufer, IV iron therapies were the only realistic alternative treatment option for patients intolerant of or unwilling to take salt-based oral iron therapies. However, use of such an invasive, costly, inconvenient and complex to administer treatment option, which is associated with potentially life-threatening and spontaneous hypersensitivity reactions, means there remains a clear unmet medical need for patients with iron deficiency to have access to an effective therapy like Accrufer® that is well tolerated, convenient and does not require hospital-based administration.

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Dr. Kamal Kant Kohli Kohli