Last year was a landmark for drug approvals from the Food and Drug Administration, with an 18-year high in the number of drugs to gain approval.
In 2014, the FDA approved 51 new therapies, including 27 to treat specialty conditions, the most since the all-time high of 53 approvals in 1996. Last year’s therapies included 41 approved through the FDA’s drug division and 10 through its biologics division.
Specialty drugs to treat rare conditions as well as complex diseases such as cancer have accounted for the majority of FDA approvals for the past four years as drug manufacturers devote more time and money to developing specialized treatments. While the majority of drugs to gain approval in 2014 were specialty drugs, several new traditional drugs to treat diabetes, allergies and pain will present new treatment options for millions of Americans.
In 2014, the FDA approved nine drugs considered to be breakthrough therapies.
Under FDA guidelines established in July 2012, drugs designated as breakthrough therapies undergo an expedited development and review process. In order to achieve the designation as a breakthrough therapy, a drug must meet the criteria that it is intended to treat a serious or life-threatening condition and that preliminary clinical evidence shows the drug may demonstrate substantial improvement over existing therapies.
The nine breakthrough drugs to gain approval last year had an average FDA review time of four months, compared to roughly 16 months for other therapies.
These medications being designated as breakthrough therapies greatly expedited the process and have opened doors for patients who previously had limited treatment options. Two drugs – Ofev® (nintedanib) and Esbriet® (pirfenidone) – were approved in October and became the first approved therapies for treating the underlying cause of idiopathic pulmonary fibrosis. Prior to approval, the only options for treating the disease were supportive care or a lung transplant.
Two breakthrough therapies to gain approval in 2014 – Zykadia™ (ceritinib) and Zydelig® (idelalisib) – are oral oncology regimens for certain types of lung cancer and blood cancer, respectively. These drugs were among 10 new oncology therapies approved last year, more evidence of increased focus on oncology medications in recent years, especially oral oncology treatments.
More Competition for Hepatitis C Treatment
On the heels of the FDA approval of Sovaldi® (sofosbuvir) in late 2013, two new drugs for treating genotype 1 hepatitis C were approved in 2014. Gilead’s Harvoni™ (ledipasvir/sofosbuvir) and AbbVie’s Viekira Pak™ (ombitasvir, paritaprevir, and ritonavir tablets; dasabuvir tablets) are the first highly effective, all-oral therapies for treating genotype 1 hepatitis C.
Roughly 3.2 million Americans are living with hepatitis C, with genotype 1 being the most common form and representing about 75% of cases. These newly approved drugs have increased competition while providing a cure for this chronic disease. The standard of care for treating patients with hepatitis C has evolved rapidly over the past year.
Expanded Treatment for Diabetes
Among traditional drugs, the treatment of Type 2 diabetes will also see increased competition. Four new diabetes medications – Farxiga® (dapagliflozin), Jardiance® (empagliflozin), Tanzeum™ (albiglutide) and Trulicity™ (dulaglutide) – were approved that will compete within established therapy classes.
These drugs will impact the lives of millions of Americans. Type 2 diabetes affects about 24 million people and accounts for more than 90% of diabetes cases in the U.S. As their disease progresses, patients may need multiple drug therapies to help control their diabetes, and these drugs provide additional treatment options.
Next week, we’ll share an overview and analysis of the drugs expected to gain FDA approval in 2015.
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