With 41 novel drug approvals under the regulators’ belts last year, 2014 represented an 18-year high for the Food and Drug Administration – including a record number of okayed meds for orphan diseases, the Associated Press says:
FDA drug approvals are considered a barometer of industry innovation and the federal government’s efficiency in reviewing new therapies. Last year’s total was the most since the all-time high of 53 drugs approved in 1996.
The 2014 approval list includes 15 drugs for so-called orphan diseases, which are rare conditions and disorders that affect fewer than 200,000 people in the U.S. Last year’s tally, which included drugs for rare cancer and metabolic disorders, exceeded the 13 orphan drugs approved in 2012.
It should be noted that many of these drugs, particularly those of the orphan persuasion, carry characteristically heavy price tags. For instance, an Amgen cancer drug is projected to cost $178,000 per year; another from Aegerion Pharmaceuticals costs $325,000 per year. The AP points out:
While the uptick in innovative medicines is good news for patients, it is sure to reinvigorate debate over the price of new drugs as insurers and public payers increasingly push back against higher costs.
AstraZeneca garnered the most approval – four – which Forbes says might have contributed to Pfizer’s acquisitive interest in its fellow pharma behemoth. It continues:
But other companies that have been hard hit by the innovation drought scored successes as well. AbbVie that had not produced an NME since 2004, made a remarkable return with Viekira Pak, its hepatitis C treatment which will likely achieve blockbuster status in 2015 thanks to its pricing agreement with Express Scripts. Lilly, which had only brought one NME to market in the last nine years, notched three approvals in cancer and diabetes.
The Forbes piece included this graph that shows all the drug and biologics approvals:
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
And this:
