Date: 2018-01-03
Type of information: Granting of a Market Authorisation in Canada
Product name: Xiidra™
Compound: lifitegrast
Therapeutic area: Ophtalmological diseases
Action mechanism:
- integrin antagonist/LFA-1 antagonist. Lifitegrast, a small-molecule integrin antagonist, was designed in order to treat dry eye disease, and is a preservative-free topical eye solution. Lifitegrast is believed to work by reducing inflammation through inhibition of lymphocyte function-associated antigen 1 (LFA-1) and preventing its binding to intercellular adhesion molecule-1 (ICAM-1) that influences T-cell activation and cytokine (protein) release. The interaction between these two proteins plays a key role in the chronic inflammation associated with dry eye. T-cells are important components of the immune system that help control the body's response to a foreign or harmful substance or stimuli. Lifitegrast is Sarcode Bioscience lead product. Shire has purchased this company in March 2013.
- The product is a twice-daily eye drop solution.
Company: Shire (UK-USA)
Disease: dry eye disease
Latest news:
- • On January 3, 2018, Shire announced that Xiidra® (lifitegrast ophthalmic solution 5%) has been approved in Canada, marking the first international approval for the treatment outside of the U.S. The approval of Xiidra® is supported by a development program consisting of five clinical trials with more than 2,500 patients. In four safety and efficacy studies, Xiidra® improved symptoms as measured by patient-reported eye dryness score (EDS), and in three of the four studies improved the objective signs of dry eye disease (measured using corneal staining). Xiidra® will be available for patients in Canada in early 2018.
- • On August 15, 2017, Shire announced that the Marketing Authorization Application (MAA) for lifitegrast, submitted on 07 August 2017, has been validated by the UK as the Reference Member State involved in the Decentralized Procedure. If approved, lifitegrast would be the first and only treatment in a new class of drugs to address the signs and symptoms of dry eye disease in adults in Europe
- • On July 11, 2016, Shire announced that the FDA has approved Xiidra™ (lifitegrast ophthalmic solution) 5%, a twice-daily eye drop solution indicated for the treatment of the signs and symptoms of dry eye disease in adult patients. Shire expects to launch Xiidra™ in the United States in the third quarter of 2016.
Xiidra™ is dosed twice per day, approximately 12 hours apart, in each eye. The safety and efficacy of Xiidra™ was studied in 1,181 patients (of which 1,067 patients received lifitegrast 5%) in four placebo-controlled 12-week trials. Each of the four studies assessed the effect of Xiidra™ on both the signs and symptoms of dry eye disease at baseline, week two, six and 12. Assessment of symptoms was based on change from baseline in patient reported eye dryness score (EDS; 0-100 visual analogue scale). Assessment of signs was based on inferior corneal staining score (ICSS; 0-4 scale). In all four studies, a larger reduction in EDS was observed with Xiidra at six and 12 weeks. In two of the four studies, an improvement in EDS was seen with Xiidra™ at two weeks. At week 12, a larger reduction in ICSS favoring Xiidra™ was observed in three of the four studies. The most common adverse reactions reported in 5 to 25 percent of patients were instillation site irritation, altered taste sensation (dysgeusia) and reduced visual acuity.
- • On February 4, 2016, Shire announced that the FDA has acknowledged receipt of the resubmission of the New Drug Application (NDA) for lifitegrast for the treatment of signs and symptoms of dry eye disease in adults. Shire resubmitted the NDA in response to the complete response letter (CRL) received from the FDA on October 16, 2015 that requested an additional clinical study and more information related to product quality. The FDA determined that the submission is a complete response and has assigned a 6-month review period for the NDA and a Prescription Drug User Fee Act (PDUFA) goal date of July 22, 2016.
The new drug application for lifitegrast now includes data from five clinical trials, including one Phase 2 study, three Phase 3 safety and efficacy studies (OPUS-1, OPUS-2 and OPUS-3) and one long-term (one year) Phase 3 safety study (SONATA).
- • On January 25, 2016, Shire announced it has resubmitted the New Drug Application (NDA) to the FDA for lifitegrast, for the treatment of signs and symptoms of dry eye disease in adults. Shire resubmitted the NDA in response to the complete response letter (CRL) the company received from the FDA on October 16, 2015. Addressing the FDA request for an additional study, Shire included in its NDA resubmission package data from OPUS-3, a Phase 3 efficacy and safety trial with a primary endpoint of patient-reported symptom improvement. The resubmission package also included information requested by the FDA regarding product quality.
- • On October 19, 2015, Shire announced that the company has recently completed a Phase 3 study of lifitegrast, OPUS-3, that, if positive, will be the basis of Shire’s response to the CRL.
- • On October 16, 2015, Shire announced that the FDA requested an additional clinical study as part of a complete response letter (CRL) to the company’s new drug application for lifitegrast for the signs and symptoms of dry eye disease in adults. Shire has recently completed a Phase 3 study of lifitegrast, OPUS-3, that is expected to be the basis of Shire’s response to the CRL. The FDA also requested more information related to product quality, which Shire will address in the CRL response. Topline results of OPUS-3 are expected before year-end, and, and if positive, the company plans to submit these data as part of a resubmission to the FDA during the first quarter of 2016.
- OPUS-3, a randomized, double-masked, 12-week Phase 3 study enrolled 711 patients to evaluate the efficacy and safety of lifitegrast. The clinical trial’s primary endpoint is patient-reported symptom improvement as measured by the Eye Dryness Score EDS scale. The new drug application for lifitegrast included data from four randomized, controlled clinical trials with more than 1,800 patients. These include one Phase 2 study, two Phase 3 efficacy and safety studies (OPUS-1 and OPUS-2), and one long-term Phase 3 safety study (SONATA).
- • On April 9, 2015, Shire announced that the FDA has accepted for filing the New Drug Application (NDA) for lifitegrast and granted a Priority Review designation. The FDA is expected to provide a decision on October 25, 2015, based on the Prescription Drug User Fee Act V action date.
- • On March 2, 2015, Shire announced that the company has submitted a New Drug Application (NDA) with the FDA for lifitegrast for the treatment of signs and symptoms of dry eye disease in adults. The NDA submission is supported by the totality of evidence from four clinical trials with more than 1,800 patients. These included one Phase 2 study, two Phase 3 efficacy and safety studies, and one long-term Phase 3 safety study.
- • On May 16, 2014, Following a May 15, 2014, meeting with the FDA, Shire announced that it intends to submit a New Drug Application for lifitegrast as a treatment for the signs and symptoms of dry eye disease in adults in the first-quarter 2015. In parallel to preparing for the NDA submission, Shire will be assessing the need for gathering additional clinical data in support of the U.S. and potential international regulatory submissions. Lifitegrast has been studied in a large clinical development program of more than 1,800 patients.
Patents:
Submission of marketing authorization application USA :
Submission of marketing authorization application UE: 2017-08-15
Withdrawal of marketing authorization application USA:
Withdrawal of marketing authorization application UE:
US authorization: 2016-07-11
UE authorization:
Favourable opinion UE:
Favourable opinion USA:
Orphan status USA:
Orphan status UE:
Pediatric exclusivit _USA:
Pediatric exclusivity UE:
OTC status:
Other news:
Is general: Yes
