Alexion Pharmaceuticals, Inc. (NASDAQ:ALXN), one of the leading biotech stocks pharmaceutical companies has announced applying for extension of the label expansion for Soliris to Japan’s Ministry of Labour and Welfare (MHLW). Soliris is used in the treatment of refractory generalized myasthenia gravis (gMG), among patients who are anti-acetylcholine receptor (AChR) antibody-positive.
Alexion used III REGAIN study results to support their application. Soliris’ supplemental Biologics License Application (sBLA) was recently accepted by the FDA. The FDA also set Oct 23 as the date to issue the Prescription Drug User Fee Act (PDUFA). The company also submitted applications for marketing and commercialization to the European Medicines Agency (EMA).
Going by the company’s biotech stocks price, Alexion has performed below the Zacks classified Medical – Biomedical and Genetics in the past one year. The stock slipped to 1.9% which is way below the 5.5% recorded by the industry.
Soliris was awarded the Orphan Drug Designation (ODD) to be used by patients with NG in Europe and the United States. The drug is already approved in the European Union, the United States and Japan and several other countries as the only medication for reduction of hemolysis in paroxysmal nocturnal hemoglobinuria (PNH) patients.
Being the company’s major drug and main source of revenue, Alexion uses Soliris for growth purposes. The drug is currently having challenges in accessing the Latin America market. Its revenues are also expected to be affected by the trial on ALXN1210.
In addition to Soliris, Alexion has launched an evaluation of ALXN1210 in the third phase studies for both aHUS and PNH. The company has also started treating patients in a phase III trial which is designed to compare Soliris to ALXN1210 intravenously administered every eight weeks
Additionally, the company is starting the third phase study of ALXN1210 which is designed to compare the candidate intravenously administered every eight weeks to patients on Soliris treatment.
The company is recruiting patients for the third phase study on ALXN1210 intravenously administered for every eight weeks in patients suffering from aHUS. Admission is expected to close in 2017.