FDA announces orphan drug designation for Veliparib as NSCLC treatment

Release Date: 18-Nov-2016

US Food and drug Association (FDA) has declared Veliparib, an oral poly (adenosine diphosphate [ADP]-ribose) polymerase (PARP) inhibitor, developed by Abbvie (ABBV). Currently, Veliparib is undergoing investigation in combination with chemotherapies, such as carboplatin and paclitaxel, or radiation for the treatment of advanced squamous non-small cell lung cancer (NSCLC).


PARP is the naturally occurring enzyme in the body that repairs damage to DNA in the cells. The process is useful to maintain the integrity of healthy cells, and can help in repairing DNA cancer cells, causing them to survive. Veliparib is currently under investigation that its combination with DNA damaging therapies, such as chemotherapy or radiation, may lessen the repair of DNA damage in cancer cells, eventually causing some cells to die.


NSCLC is the common type of lung cancer in the US accounting for 80 to 85% of diagnosed cancer cases. Survival from lung cancer depends on the stage at which cancer is diagnosed.


The FDA Orphan Drug Designation is granted to medicines and biologics that are defined as those intended for the safe and effective treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the U.S., or that affect more than 200,000 persons but are not expected to recover the costs of developing and marketing a treatment medicine.


For Orphan Drug Clinical Insight Reports Contact:  neeraj@kuickresearch.com

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