29, 2015); In re Thalomid
& Revlimid Antitrust Litig., No.
As mandated by the US Food and Drug Administration, Thalomid
is subject to Risk Evaluation and Mitigation Strategies program, which is designed and implemented during the commercialisation of a pharmaceutical product to ensure an acceptable risk-to-benefit ratio for products that are known to exhibit specific risks.
He presented an update of a study that was sponsored by Celgene Corp., the maker of Thalomid
. The trial involved 180 patients who were treated with thalidomide starting at a dosage of 200 mg/day and escalating to a maximum dosage of 800 mg/day every 2 weeks as tolerated.
Celgene promoted Thalomid
for the treatment of multiple myeloma before its approval in May 2006.
The litigation was mainly regarding allegations that the company promoted Thalomid
(thalidomide) for off-label uses before its 2006 FDA approval for newly diagnosed multiple myeloma.
Celgene Corp., which involves allegations that Celgene has prevented Mylan from offering competing generic versions of Celgene's brand drug products, Thalomid
and Revlimid, by precluding them from obtaining samples of those drugs to perform necessary testing.
In 2009, the drugs Gleevec (imatinib mesylate), Sutent (sunitinib malate), Tarceva (erlotinib), Thalomid
(thalidomide), and Tykerb (lapatinib) will all be placed on a top formulary tier, with beneficiaries having to pay 26%-35% of the drugs' cost.
Celgene would gain Vidaza, a treatment for blood cancer, as part of the deal, boosting its own pipeline of products, which include Revlimid and Thalomid
. Revlimid is a direct competitor to Vidaza.
The safety and effectiveness of Kyprolis, which is administered directly into a patient s vein (intravenously), was evaluated in a study of 266 patients with relapsed multiple myeloma who had received at least two prior therapies, including Velcade and Thalomid
* There are many examples of repositioned drugs, including Lilly's Evista (raloxifene), which began clinical trials for breast cancer but was developed for osteoporosis, Celegene's Thalomid
(halidomide), which began as a treatment for nausea in pregnant women and is now on the market for the treatment of leprosy, and Pfizer/NTektar's Exubera, reformulated inhaled insulin.
The US-based global pharmaceutical company, which now owns thalidomide, sells it under the brand name Thalomid
* DDMAC also cited Celgene for sales representative promotion of its product, Thalomid
, which was approved at the time only for use in the acute treatment of the cutaneous manifestations of moderate to severe erythema nodosum leprosum (ENL) and as maintenance therapy for prevention and suppression of the cutaneous manifestations of ENL recurrences.