Once Daily Fosamprenavir (Lexiva) Boosted with Either 100 mg or 200 mg Ritonavir (Norvir): Efficacy Results from COL100758

GlaxoSmithKline to Discontinue Sales of Protease Inhibitor Amprenavir (Agenerase)

GlaxoSmithKline (GSK) has decided to take the protease inhibitor (PI) amprenavir (Agenerase) off the market. The decision is based primarily on the success of GSK's fosamprenavir (Lexiva), a prodrug of amprenavir that is used with low-dose ritonavir (Norvir). Following is the text of the GSK announcement about the discontinuation of amprenavir as well as a link to the content of a letter sent to healthcare providers:

Recently GlaxoSmithKline introduced LEXIVA (fosamprenavir) Oral Suspension for treatment of HIV-1 infection, including dosing recommendations for children ages 2 to 12 and for adults with hepatic impairment. The availability of this new formulation of LEXIVA, as well as the introduction of other novel protease inhibitors over the last several years, have greatly diminished the clinical demand for GSK’s other protease inhibitor, AGENERASE® (amprenavir) Oral Solution and 50 mg Capsules. Fosamprenavir is a prodrug of amprenavir.

As a result of this new approval, GlaxoSmithKline’s has decided to discontinue the sale of AGENERASE® (amprenavir) Oral Solution and 50 mg Capsules in the US by the end of October 2007. In an effort to ensure that patients and physicians have adequate time to consult on appropriate alternative protease inhibitor or antiretroviral treatment regimens, the supply of AGENERASE Oral Solution and 50 mg Capsules in the U.S. will continue to be available at the pharmacy level until February 2008.

In the interest of patient care, patients currently receiving AGENERASE through the GlaxoSmithKline Bridges to Access patient assistance program who decide to switch to LEXIVA can also obtain coverage under this program once the appropriate documentation is submitted to the company.

The recently distributed Dear Healthcare Provider letter about this product discontinuation is below.

Re: Discontinuation of AGENERASE® (amprenavir) Oral Solution and 50 mg Capsules in the US

Dear Healthcare Provider:

This letter is intended to inform you that GlaxoSmithKline will be discontinuing the sale of AGENERASE Oral Solution and 50 mg Capsules in the US by the end of October 2007.

This action is not the result of any safety or efficacy issues regarding these products. GlaxoSmithKline has taken this action because the clinical demand for AGENERASE Oral Solution and 50 mg Capsules has diminished significantly, and because the US Food

and Drug Administration (FDA) recently approved LEXIVA® (fosamprenavir calcium) Oral Suspension for the treatment of HIV-1 infection, including dosing recommendations for children ages 2 to 18 and for adults with hepatic impairment.

LEXIVA is the prodrug of AGENERASE. Both AGENERASE and LEXIVA are indicated in combination with other antiretroviral agents for the treatment of HIV infection.

Because of this discontinuation, please refrain from initiating treatment with AGENERASE Oral Solution or 50 mg Capsules in your patients with HIV infection. We encourage you (or the prescribing health care provider) to discuss appropriate alternative protease inhibitors or antiretroviral treatment regimens with your patients currently receiving AGENERASE Oral Solution or 50 mg Capsules.

LEXIVA may be an appropriate alternative option when transitioning your patients from the AGENERASE Oral Solution or 50 mg Capsules as LEXIVA is the prodrug of AGENERASE.

LEXIVA Oral Suspension is available as a 50 mg/mL liquid preparation.

If you wish to transition your patients to LEXIVA Oral Suspension, dosing with LEXIVA may be initiated at the time of the next scheduled AGENERASE dose, without the need for a wash-out period or loading dose.

In pediatric patients at least 2 years of age already receiving AGENERASE Oral Solution (without ritonavir), the appropriate dose of LEXIVA Oral Suspension without ritonavir is 30 mg/kg twice daily, up to the adult maximum dose of LEXIVA 1400 mg twice daily.

LEXIVA may also be administered with ritonavir to pediatric patients at least 6 years of age at a dose of LEXIVA 18 mg/kg plus ritonavir 3 mg/kg twice daily, not to exceed the adult dose of LEXIVA 700 mg plus ritonavir 100 mg twice daily.

11/06/07

Source
GlaxoSmithKline