The CSL Ltd (ASX: CSL) share price has risen after the ASX healthcare share announced approval for its healthcare product in the US by the FDA.
CSL says it’s a global biotechnology company with a dynamic portfolio of lifesaving medicines, including those that treat hemophilia and immune deficiencies, vaccines to prevent influenza, and therapies in iron deficiency and nephrology. Its three businesses of CSL Behring, CSL Seqirus and CSL Vifor provide lifesaving products to patients in more than 100 countries and it employs 32,000 people.
FDA approval
CSL announced to the ASX that the US Food and Drug Administration (FDA) has approved ANDEMBRY for immediate launch in the US, which is good news for the CSL share price.
What does ANDEMBRY do? It helps prevent attacks on hereditary angioedema (HAE). According to CSL, it is the first and only treatment targeting XIIa for prophylactic use to provide sustained protection from attacks of HAE in adult and pediatric patients aged 12 or older.
The ASX healthcare share said HAE occurs in about 1 in 50,000 people of any ethnic group.
CSL also said that ANDEMBRY is the only treatment to offer once-monthly dosing from the start for all patients and is administered through an autoinjector.
CSL then explained how it works and how effective it is. The company said it inhibits the top of the HAE cascade by targeting factor XIIa. The ASX healthcare share explained:
The pivotal placebo-controlled Phase 3 VANGUARD trial and its open-label extension study showed ANDEMBRY reduced the median number of HAE attacks by more than 99 percent and a least squares mean of 89.2 percent, compared to placebo.
CSL said this FDA approval builds on other recent approvals for the treatment in Australia, the UK, the EU, Japan, Switzerland, and the UAE.
Final thoughts on the CSL share price
CSL said it will launch ANDEMBRY in the US immediately, with availability achieved through its third-party specialty pharmacy network before the end of June.
The company didn’t mark this announcement to the ASX as market-sensitive, so it probably won’t too much of a difference to its bottom line. But, it’s good to see that the FDA is still willing to approve CSL products after all of the changes in the US administration’s healthcare operations.
There are other ASX growth shares I’d rather buy first with more clear growth prospects.
