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Date: 2017-09-22

Type of information: Granting of a Market Authorisation in the US

Product name: Prolastin®-C Liquid

Compound: alpha-1 proteinase inhibitor

Therapeutic area: Rare diseases - Genetic diseases

Action mechanism:

  • enzyme replacement therapy. Prolastin®-C Liquid is the first liquid formulation of an alpha-1 antitrypsin deficiency replacement therapy manufactured in the U.S. This plasma-derived product will be also manufactured at Grifols’ industrial complex in Parets del Vallès (Barcelona, Spain) following the same production process once the new alpha-1 purification and filling plant comes into operations. Grifols has invested € 45.4 million toward the new plant, which will have a production capacity of 4.3 million equivalent liters of plasma in both freeze-drying and liquid formulations.

Company: Grifols (Spain)

Disease: alpha-1 antitrypsin deficiency

Latest news:

  • • On September 22, 2017. Grifols announced the approval from the FDA for a liquid formulation of its alpha-1 antitrypsin (Prolastin®-C Liquid) as a replacement therapy to treat alpha-1 antitrypsin deficiency. This rare genetic disorder affects approximately 25 per 100,000 people1 which can lead to pulmonary emphysema without adequate treatment. Moreover, it represents the most common cause of liver disease in children. The approval process for the product has also commenced in Europe. The commercial launch of Prolastin®-C Liquid is scheduled for 2018.

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: 2017-09-22

UE authorization:

Favourable opinion UE:

Favourable opinion USA:

Orphan status USA:

Orphan status UE:

Pediatric exclusivit _USA:

Pediatric exclusivity UE:

OTC status:

Other news:

Is general: Yes