Amgen Inc. (NASDAQ:AMGN) Receives Positive CHMP Opinion For Delivery System Of Neulasta

Amgen Inc. (OTCMKTS:AMGN) has announced that the committee for medicinal products for human use for the Europeans medical agency issued a positive opinion that recommends a label variation for Neulasta.

The Neulasta Onpro Kit pts together the efficacy of Neulasta to an inventive on-body injector (OBI) delivery system. Neulasta has been indicated for the reduction in the period of neutropenia and the incidence of febrile neutropenia for the adult patients.

Having more than 30 years in experience for granulocyte-colony stimulating factor research, Amgen has made commitments in providing inventive solutions and in developing new ways to help increase on the patient experience.

David M. Reese, the company’s MD said that improving the patients experience helps bring value to the healthcare providers and the health systems at large.

The Neulasta Onpro Kit is a display of our patient-tailored approach and the continued investment in advancing the field of G-CSF administration. The improved administration option provides patients with a greater freedom and experience.

Besides that it also provides timed deliveries that provide a piece of mind to the patients, the physicians and the care givers having the believe that this will help fight the risks attributed to its infections.

Among the side effects of chemotherapy is that it highly decreases the activeness of the bone marrow. Febrile neutropenia is a life threatening condition that is associated to increased risks of being hospitalized which is a very risky and costly affair.

After the CHMP positive recommendation, the centralized European marketing authorization of Neulasta will have to be updated to encompass the delivery systems of the OBI in their original labels.

Febrile neutropenia is complicated by a fever. Fever is mostly an indication of infection and fro the patients who are in receipt of Myelo suppressive chemotherapy, this can be the only symptom.

Neulasta received its approval for use in Europe back in the year 2002 and has shown effectiveness in decreasing the incidences of the high infections.

Neulasta has also been said to increase the survival for patients who have been exposed to the myelosuppressive radiation doses. Neulasta has not been indicated for mobilization.