USV announces successful completion of pivotal clinical studies for its Pegfilgrastim

Our Bureau, MumbaiThursday, August 31, 2017, 16:15 Hrs  [IST]

USV Pvt. Ltd, an Indian pharmaceutical company, based in Mumbai, completed phase I and phase III studies of USV Pegfilgrastim as per EU guidelines. USV Pegfilgrastim is used to boost white blood cells in cancer patients and is prescribed for the reduction in duration of Neutropenia and the incidence of fever in adult patients suffering from Neutropenia.

Neutropenia usually occurs in patients treated with cytotoxic chemotherapy for malignancy. Neutropenia is known to increase susceptibility to infections. The studies indicated that the pharmacokinetics (PK) and pharmacodynamics (PD) of USV’s Pegfilgrastim was comparable to that of Amgen’s Neulasta in healthy patients and it also had a comparable efficacy and safety profile in breast cancer patients.

Prashant Tewari, Managing Director, USV Pvt. Ltd. said – “Neutropenia, an abnormally low concentration of neutrophils (white blood cells), is commonly observed in patients being treated with chemotherapy. Neutrophils play a key role in the host defence against bacterial infections and in acute inflammatory response. USV’s Pegfilgrastim reduces the duration of Neutropenia and therefore the chances of infection. The successful completion of this study would mean we will soon have a biosimilar product that can have potential life saving as well as cost benefits for these patients.”

The Phase III study was conducted to compare the duration of severe neutropenia (DSN) observed after treatment with USV Pegfilgrastim or Neulasta. In this study, 254 patients of breast cancer scheduled to receive chemotherapy were randomized in 2:1 proportion to two groups and were treated with either USV Pegfilgrastim or Neulasta. USV Pegfilgrastim or Neulasta was administered 24 hours after the administration of myelosuppresive chemotherapy consisting of docetaxel, doxorubicin and cyclophosphamide. USV Pegfilgrastim demonstrated equivalence to Neulasta and the profile of adverse events was comparable in both the groups. Therefore, a comparable efficacy and safety profile was observed for USV Pegfilgrastim and Neulasta.

Two Phase I studies were conducted to compare pharmacokinetics (PK) and pharmacodynamics (PD), one at therapeutic dose (6mg) and second at low dose (2mg)  as per the EU guidelines and the scientific advices sought from the European medicine agency (EMA) from time to time. The primary endpoints for PK/PD were met, signifying a comparable profile. With successful completion of the clinical studies, the submission of dossier for the Marketing authorization application (MAA) has been planned in Q4 2017.

Pegfilgrastim is a recombinant form of granulocyte colony stimulating factor (G-CSF), which is indicated for reduction in the duration of Neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for malignancy (with exception of chronic myeloid leukemia and myelodysplastic syndromes). The product USV Pegfilgrastim is a proposed biosimilar to Amgen’s Neulasta and is wholly developed by USV.