With new treatments poised to gain FDA approval for heart failure and high cholesterol, combined with the emerging potential for biosimilars to impact the market, 2015 is shaping up to be a notable year for pharmaceuticals.
Several pipeline products – including blockbuster drugs with the potential for more than $1 billion in annual sales – will influence drug spend significantly by the end of 2015. Their impact for large patient populations combined with their potentially high cost definitely makes them drugs to watch.
Biosimilars Reach the U.S.
On March 6, the FDA approved the biosimilar ZarxioTM (filgrastim-sndz), which will compete with Neupogen® (filgrastim) – a blockbuster treatment used to decrease rates of infection in certain cancer patients during chemotherapy. Neupogen accounted for $1.2 billion in U.S. drug spend last year.
InflectraTM (infliximab), a biosimilar to Remicade® (infliximab), may gain approval as early as June and would be the first monoclonal antibody biosimilar. It could be indicated in all uses approved for Remicade, including rheumatoid arthritis, psoriasis, psoriatic arthritis, Crohn’s disease, ulcerative colitis and ankylosing spondylitis. Remicade U.S. sales totaled $4.5 billion last year.
Patent litigation disputes between the biosimilar and brand manufacturers are ongoing and will likely delay the availability of these drugs.
The FDA is currently reviewing injected specialty drugs that lower cholesterol for certain patients through inhibition of proprotein convertase subtilisin/kexin type 9 (PCSK9 inhibitors). These drugs will offer additional treatment options for patients and are projected to cost thousands of dollars per patient annually.
Numerous ongoing clinical trials are looking at their use in concert with statins. If trials show they improve cardiovascular outcomes, use of these therapies could be extensive. The total U.S. expenditure on these drugs alone could eventually become more than $100 billion annually, an unprecedented amount for a single class of drugs.
New Treatments for Heart Failure
About 5.7 million Americans have heart failure – a chronic, progressive condition in which the heart is unable to pump enough blood to meet the body’s need for blood and oxygen. Approximately half of the people who develop heart failure die within five years of diagnosis.
Depending on the severity of illness, patients may manage their condition with dietary sodium and fluid restrictions, physical activity and attention to weight gain. Current prescription drug therapies include diuretics, vasodilators, inotropic agents, anticoagulants and beta-blockers.
Procoralan® (ivabradine) could gain FDA approval as soon as May. It will be used in combination with standard therapy for patients with chronic heart failure. It also will benefit patients for whom beta-blocker therapy is contraindicated or not tolerated and who continue to have an increased resting heart rate of 70 beats per minute or higher despite treatment. Up to 100,000 patients with chronic heart failure may be eligible for this new therapy.
A second heart failure drug, LCZ696, has been granted priority review by the FDA. This designation accelerates the review of therapies that may offer a significant improvement in the safety or effectiveness of a treatment, prevention or diagnosis of a serious condition. Approval is expected in August.
A trial of LCZ696 was stopped early citing improved outcomes in patients taking the study drug. Risk of hospitalization for heart failure was reduced by 21%, risk of death from cardiovascular causes by 20% and risk of all-cause mortality by 16%. The estimated population size could be up to half of the 5.7 million Americans with heart failure.
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