FDA Approves New Oral Alzheimer’s Therapy, Expands Label for Grifols’ SCIg Therapy

 July 29

Product: Alpha Cognition’s Zunveyl

Indication: Alzheimer’s disease

There’s a new Alzheimer’s treatment on the market. Monday, the FDA gave the go-ahead to Alpha Cognition’s Zunveyl as just the second oral therapy approved this decade for Alzheimer’s disease.

Zunveyl was designed to eliminate drug absorption in the GI tract, potentially addressing tolerability issues with leading Alzheimer’s drugs, according to Alpha Cognition. A prodrug of galantamine and an acetylcholinesterase inhibitor, Zunveyl is thought to work by preventing the breakdown of acetylcholine, a neurotransmitter involved in memory, motivation and attention functions.

Zunveyl’s approval is backed by chemistry, manufacturing and controls information and data demonstrating its bioequivalence and tolerability compared to galantamine immediate-release tablets and galantamine extended-release capsules. Minimal adverse events were reported in these trials, according to the company’s press release.

July 29

Product: Grifols’ Xembify

Indication: Primary humoral immunodeficiencies

Treatment-naïve patients with primary humoral immunodeficiencies can now access Grifols’ Xembify after the FDA approved an expanded label for the subcutaneous immunoglobulin treatment (SCIg). Patients will now be eligible to begin treatment with Xembify without initial intravenous administration. With the approval, Xembify becomes the first 20% SCIg with an extended label for treatment-naïve patients, according to its maker.

The FDA has additionally greenlit biweekly dosing of the SCIg therapy, backed by a Phase IV trial that showed non-inferiority in total Ig levels compared to weekly administration. Grifols intends to launch the new label this quarter.

This is the second win for Grifols in as many months, after the FDA approved Yimmugo, an intravenous immunoglobulin (Ig) therapeutic, to treat primary immunodeficiencies developed by its subsidiary Biotest.

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