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Date: 2017-12-11

Type of information: Granting of a Fast Track status

Product name: PBI-4050 - 3-pentylbenzenacetic acid sodium salt

Compound: 3-pentylbenzenacetic acid sodium salt

Therapeutic area: Lung diseases - Respiratory diseases - Rare diseases

Action mechanism:

  • antifibrotic agent

Company: ProMetic Life Sciences (Canada)

Disease:

  • idiopathic pulmonary fibrosis

Latest news:

  • • On December 11, 2017, Prometic Life Sciences announced today that its orally-active drug candidate, PBI-4050, has been issued a Promising Innovative Medicine (PIM) designation by the United Kingdom (UK) Medicines and Healthcare Products Regulatory Agency (MHRA) as add-on treatment to nintedanib in patients with idiopathic pulmonary fibrosis (IPF).
  • A PIM designation is an early indication that a medicinal product is a promising candidate for the Early Access to Medicines Scheme (EAMS), intended for the treatment, diagnosis or prevention of a life-threatening or seriously debilitating condition with unmet medical need. The PIM designation is a prerequisite to proceed to the EAMS scientific opinion assessment phase, the second and final step in the EAMS process. The EAMS provides an opportunity for important drugs to be used in UK clinical practice in parallel with the later stages of the regulatory process. It is anticipated that medicines with a positive EAMS opinion could be made available to patients 12 – 18 months before receiving marketing authorization.
  • • On September 1-3, 2015, the Committee for Orphan Medicinal Products (COMP) has recommended the granting of an orphan designation for 3-pentylbenzeneacetic acid sodium salt for treatment of idiopathic pulmonary fibrosis.
  • • On February 11, 2015, the FDA has granted orphan drug designation for 3-pentylbenzenacetic acid sodium salt for the treatment of idiopathic pulmonary fibrosis.

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: 2015-02-11

Orphan status UE: 2015-10-09

Pediatric exclusivit _USA:

Pediatric exclusivity UE:

OTC status:

Other news:

Is general: Yes