Expanded Access Program With Lanadelumab for Japanese People With Hereditary Angioedema

Inclusion Criteria:

1. In the opinion of the Investigator, the participant is capable of understanding andcomplying with protocol requirements.
2. Be of Japanese descent, defined as born in Japan and having Japanese parents andJapanese maternal and paternal grandparents.
3. Male and female HAE participants who are 12 years of age or older at the time ofscreening.
4. Documented diagnosis of disease HAE (Type I or II) based on all of the following:

• Documented clinical history consistent with HAE (subcutaneous [SC] or mucosal,nonpruritic swelling episodes without accompanying urticaria).
• Diagnostic testing results obtained during screening (or a prior lanadelumabstudy) that confirm HAE Type I or II: C1-inhibitor (C1-INH) functional level <40%of the normal level. Participants with functional C1-INH level 40% to 50% of thenormal level may be enrolled if they also have a C4 level below the normal range.Participants may be retested if results are incongruent with clinical history orbelieved by the Investigator to be confounded by long-term prophylaxis (LTP) use.It is understood that C1-INH therapy may alter the lab results of C1-INHassessments; therefore, the Investigator's discretion in collaboration withsponsor is advised for proper documentation of eligibility.
• At least one of the following: Age at reported onset of first angioedema symptoms =<30 years, a family history consistent with HAE Type I or II, or C1q withinnormal range.

5. Non-rollover participants only: A historical baseline HAE attack rate of at least 1attack per 4 weeks in the recent 1 year.
6. Rollover participants only: Participants from Study SHP643-302 are permitted torollover and enroll into this study if:

• They completed the treatment period of Study SHP643-302; and
• They consented to enter Study TAK-743-5007 on or before Day 350 of the SHP643-302study (since Day 378 of Study SHP643-302 is also Day 0 of Study TAK-743-5007,informed consent may be completed on Day 364 or this visit, if not alreadyprovided).

7. Adult participants and caregivers of subjects under the age of 20 are willing and ableto read, understand, and sign an informed consent form. Participants aged 12 to 19,whose caregiver has provided informed consent, are willing and able to read,understand and sign an informed consent form (an assent form, if applicable) as muchas possible.
8. Agree to adhere to the protocol-defined schedule of treatments, assessments, andprocedures.
9. Males and females who are fertile and sexually active must adhere to contraceptionrequirements for the duration of the study as follows:

• Females of childbearing potential must agree to be abstinent or it is recommendedto use highly effective forms of contraception from the screening period through 70 days after the final study visit.
• Females of nonchildbearing potential, defined as surgically sterile (statuspost-hysterectomy, bilateral oophorectomy, or bilateral tubal ligation) orpostmenopausal for at least 12 months do not require contraception during thestudy.
• Males, including males who are surgically sterile (post-vasectomy), with femalepartners of childbearing potential must agree to be abstinent or else use amedically acceptable form of contraception from the screening period through 70days after the final study visit.

Exclusion Criteria:

1. If rolling over from Study SHP643-302, presence of important safety concerns thatwould preclude participation in this study.
2. Concomitant diagnosis of another form of chronic, recurrent angioedema such asacquired angioedema, HAE with normal C1-INH (also known as HAE Type III/normalC1-INH), idiopathic angioedema, or recurrent angioedema associated with urticaria.
3. Dosing with an investigational drug (not including lanadelumab or other HAE therapies)or exposure to an investigational device within 4 weeks prior to screening.
4. Exposure to angiotensin-converting enzyme (ACE) inhibitors within 4 weeks prior toscreening or any newly initiated or dose modification of estrogen-containingmedications with systemic absorption (such as oral contraceptives or hormonalreplacement therapy) 3 months prior to the screening visit.
5. Unwilling to discontinue short or long-term prophylactic therapy for HAE, eg, C1-INH,attenuated androgens or anti-fibrinolytics within 3 weeks after starting the treatmentperiod. Short-term prophylaxis is defined as C1-INH, attenuated androgens, orantifibrinolytic used to avoid angioedema complications from medically indicatedprocedures.
6. Any of the following liver function test abnormalities: alanine aminotransferase (ALT) >3 × upper limit of normal (ULN), or aspartate aminotransferase (AST) >3 × ULN, ortotal bilirubin >2 × ULN (unless the bilirubin elevation is a result of Gilbert'ssyndrome).
7. Pregnancy or breast feeding.
8. Have any uncontrolled underlying medical condition which would require treatmentadjustment during the study treatment period, that, in the opinion of the Investigatoror sponsor, may confound the results of the safety assessments or may place theparticipant at risk. Participants with stable treatment for at least 3 months prior toscreening and NOT expecting any change to their treatment regimen for 6 months duringthe study treatment period, will not be excluded.
9. Participant has a known hypersensitivity to the study drug or its components.