Orphan Europe S.A.R.L. Gets EU Nod For Cystadrops
The European Commission and the US Food and Drug Administration have both granted Orphan Drug Designation to Boehringer Ingelheim's Ofev (nintedanib) for the treatment of systemic sclerosis, including the associated interstitial lung disease (SSc-ILD).
On the heels of an August study that spotlit big price hikes for certain orphan drugs, IMS Health and Celgene researchers have published some numbers of their own. A years-long upswell in orphan drug spending should slow down, and worries about unsustainable growth in orphan drug costs are unfounded, the authors say.
Passed in 1983, the Orphan Drug Act (ODA) has spurred development of hundreds of rare disease drugs that may have not otherwise seen the light of day. But many drugs under the “orphan” umbrella are used on-label and off-label to treat more common maladies, and those uses have been associated with big price increases, a new report says.