Designation of Leuprorelin Acetate (Lucrin) as an Orphan Drug - AbbVie Pty Ltd

Overview

The Designation of Leuprorelin Acetate (Lucrin) as an Orphan Drug instrument, gazetted on 19 December 2012, designates leuprorelin acetate (Lucrin) as an orphan drug for the treatment of Central Precocious Puberty (CPP). This designation was made by Dr Anthony Gill, acting as the Delegate of the Secretary under the Therapeutic Goods Regulations 1990. The policy objective behind this designation is to encourage the development and availability of treatments for rare and neglected diseases, which are often not commercially viable for pharmaceutical companies to invest in due to the small patient population. By recognising leuprorelin acetate (Lucrin) as an orphan drug, the Australian Government provides incentives such as research grants, tax benefits, and priority review to the sponsor, AbbVie Pty Ltd, to help address the unmet medical need for effective treatments of CPP.

Scope and Application

The designation of leuprorelin acetate (LUCRIN) as an orphan drug under the Therapeutic Goods Regulations 1990 applies to the treatment of Central Precocious Puberty (CPP). This Act designates the specific drug, leuprorelin acetate, for the stated medical condition, with the injection form being relevant for this indication. The sponsor responsible for this designation is AbbVie Pty Ltd, thereby implicating the entity in compliance with the relevant regulations and any associated obligations. The geographic reach of this designation is inherently national, as it pertains to the regulation of therapeutic goods within Australia. The application of this designation does not specify exclusions, exemptions, or thresholds within the text, but it is governed by the broader framework of the Therapeutic Goods Regulations 1990. The scope of this Act is limited to the specific drug and its designated use, with any broader or supplementary provisions potentially addressed in subordinate instruments.

Key Provisions

The primary provision of the legislation (C2013G00070) designates leuprorelin acetate (LUCRIN) as an orphan drug for the treatment of Central Precocious Puberty (CPP) as of 19 December 2012 (Section 1). Leuprorelin acetate (LUCRIN), manufactured by AbbVie Pty Ltd, is specifically designated for the treatment of this condition through its injection dose form. This designation is made under the Therapeutic Goods Regulations 1990 (the Regulations) and specifically under subregulation 16J (2) of the Regulations. Under this Act, certain obligations and requirements are placed on the designated parties. The sponsor, AbbVie Pty Ltd, must ensure that leuprorelin acetate (LUCRIN) adheres to the standards and criteria set forth for orphan drugs. This includes ensuring that the drug is manufactured, labelled, and distributed in compliance with the Therapeutic Goods Act 1989 and the Regulations. The sponsor also has a responsibility to provide accurate and up-to-date information about the drug, including any clinical trial data, to the Therapeutic Goods Administration (TGA) as required. The legislation also addresses the potential consequences for non-compliance with the provisions of the Act. While the specific offences, penalties, or consequences are not detailed within the text of the legislation, breaches of the Therapeutic Goods Act 1989 and the Therapeutic Goods Regulations 1990 can lead to a range of civil and criminal penalties. For example, contravening the Act or Regulations can result in fines, imprisonment, or both, depending on the nature and severity of the breach. Additionally, the TGA has the authority to take enforcement actions such as product recalls, prohibitions on sale, or other regulatory actions against non-compliant products. These measures are intended to ensure that therapeutic goods, including orphan drugs, meet the necessary safety, quality, and efficacy standards.