US patients with idiopathic pulmonary fibrosis will no doubt welcome news that regulators have approved the first two medicines for the progressive and fatal lung disease.
Boehringer Ingelheim’s Ofev (nintedanib) and Roche’s Esbriet (pirfenidone) had been neck and neck in the race to market, but have now bagged simultaneous clearance from the US Food and Drug Administration, significantly expanding the treatment options available to healthcare professionals and patients.
Ofev and Esbriet were both assigned with fast track, priority review, orphan product, and breakthrough designations, and both were also approved miles ahead of their expected decision dates of January 2, 2015, and November 23, 2014, respectively.
The approvals came on the back of clinical data showing that the decline in forced vital capacity – the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible – was significantly reduced in patients receiving either Esbriet or Ofev compared to those taking a placebo.
However, the issue of price and affordability will no doubt rear its ugly head again, given that Esbriet, acquired by Roche through its recent purchase of InterMune, will cost an eye-watering $94,000 a year. It is already available in Europe.
Nevertheless, a spokesperson for Roche's Genentech unit told PharmaTimes Digital that the firm and Intermune are committed to ensuring medicines "get to the people who need them even if they can’t afford them".
As such, InterMune offers a patient support programme, called Esbriet CareConnect, which not only offers advice on insurance coverage and financial assistance programmes, but also the potential for: a 45-day free trial supply; co-pay assistance; and free medicine for eligible patients who are uninsured or rendered uninsured.
More than 100,000 patients in the USA are affected by IPF, a condition characterised by lung scarring that causes shortness of breath and cough. Current treatments include oxygen therapy, pulmonary rehabilitation, and lung transplant, and average life expectancy is just two to five years after diagnosis, so there remains significant unmet need for patients.
The Coalition for Pulmonary Fibrosis has applauded the approval of Ofev and Esbriet, the first drugs approved for the disease in the US.
"It is a historic for IPF patients with two first-ever treatments for IPF being approved by the FDA," said Mishka Michon, chief executive of the group. "With these therapies comes hope for a brighter future for patients and renewed optimism regarding the battle against IPF amongst physicians and researchers."