Date: 2014-12-16
Type of information: Granting of the orphan status in the EU
Product name: pegylated recombinant human hyaluronidase PH20
Compound: pegylated recombinant human hyaluronidase PH20
Therapeutic area: Cancer - Oncology - Rare diseases
Action mechanism: enzyme. PEGPH20 is an investigational PEGylated form of Halozyme's proprietary recombinant human hyaluronidase under development for the systemic treatment of tumors that accumulate hyaluronan. Halozyme is currently conducting a Phase 2 study on the treatment of metastatic pancreatic cancer with PEGPH20 in combination with gemcitabine and nab-paclitaxel.
Company: Pharm. Research Associates (UK) Limited - Halozyme Therapeutics (USA - CA)
Disease: pancreatic cancer
Latest news: * On November 11-13, 2014, the Committee for Orphan Medicinal Products (COMP) has recommended the granting of an orphan designation for pegylated recombinant human hyaluronidase PH20 for treatment of pancreatic cancer.
Patents:
Submission of marketing authorization application USA :
Submission of marketing authorization application UE:
Withdrawal of marketing authorization application USA:
Withdrawal of marketing authorization application UE:
US authorization:
UE authorization:
Favourable opinion UE:
Favourable opinion USA:
Orphan status USA: 2014-10-01 (Halozyme Therapeutics - USA - CA)
Orphan status UE: 2014-12-16
Pediatric exclusivit _USA:
Pediatric exclusivity UE: OTC status: Other news:
