Insmed Incorporated (INSM - Free Report) announced that the FDA has granted an accelerated approval to amikacin liposome inhalation suspension to treat a chronic lung disease and to be marketed by the trade name, Arikayce.
The drug is approved as part of a combination antibacterial drug regimen for the treatment of lung disease caused by mycobacterium avium complex (MAC) in adult patients, left with a few or no treatment options.
Arikayce is to be administered as once daily dose using the Lamira Nebulizer System.
However, Arikayce comes with a strict boxed warning against a potential risk of adverse respiratory side effects associated with its use. Patients taking the drug will be provided with a medication guide and a step-by-step instruction manual for using the product. The company confirmed the drug’s imminent launch and its availability through specialty pharma stores in the coming weeks.
Under the accelerated approval program, the FDA grants conditional approval to a drug that fulfills an unmet medical need for a serious condition, based on early evidence suggesting clinical benefit. However, continued approval for Arikayce may be contingent upon verification and description of clinical benefit in confirmatory studies.
Arikayce is the first and the only approved treatment in the United States for patients with MAC lung disease, not responding to other conventional therapies.
The accelerated approval was based on positive data from an ongoing phase III CONVERT study. Top-line findings from the CONVERT program, presented last year, for treatment-refractory nontuberculous mycobacterial (NTM) lung disease caused by MAC.
Results showed that the addition of ALIS (amikacin liposome inhalation suspension) to guideline-based therapy (GBT) eliminated the evidence of treatment-refractory NTM lung disease caused by MAC.
Insmed is also conducting an additional clinical study to support the FDA’s full approval of the drug. The company expects to provide updates on the same in collaboration with the regulatory body.
Shares of Insmed have plunged 35.1% year to date, comparing unfavorably with the industry’s decrease of 1.2%.
Zacks Rank & Stocks to Consider
Insmed currently carries a Zacks Rank #3 (Hold). Better-ranked stocks in the healthcare sector include Ligand Pharmaceuticals Incorporated (LGND - Free Report) , Cambrex Corporation (CBM - Free Report) and Illumina, Inc. (ILMN - Free Report) , all sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
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